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HPN October 2016

Issue 31

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication

Winner's Edition

IN THIS ISSUE:

That Enstilar moment ®

NEWS: Capacity extension critical says IHCA Page 5 CONFERENCE: Biopharmaceutical Ambition at TCD Page 8

Discover what the NEW foam spray Enstilar can do for your plaque psoriasis patients

Extraordinary Delivery

Visit www.enstilar.ie Abbreviated Prescribing Information for Enstilar® 50 micrograms/g + 0.5 mg/g cutaneous foam Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.ie) before prescribing. Indication: Topical treatment of psoriasis vulgaris in adults. Active ingredients: 50 µg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate). Dosage and administration: Apply by spraying onto affected area once daily. Recommended treatment period is 4 weeks. The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A twosecond application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand. If using other calcipotriol-containing medical products in addition to Enstilar, the total dose of all calcipotriol-containing products should not exceed 15 g per day. Total body surface area treated should not exceed 30%. Safety and efficacy in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Safety and efficacy in children below 18 years have not been established. Shake the can for a few seconds before use. Apply by spraying, holding the can at least 3 cm from the skin, in any orientation except horizontally. Spray directly onto each affected skin area and rub in gently. Wash hands after use (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body. Avoid application under occlusive dressings since systemic absorption of corticosteroids increases. It is recommended not to take a shower or bath immediately after application. Contraindications: Hypersensitivity to the active substances or any of the excipients. Erythrodermic and pustular psoriasis. Patients with known disorders of calcium metabolism. Viral (e.g. herpes or varicella) skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds. Precautions and warnings: Adverse reactions found in connection with systemic corticosteroid treatment, e.g. adrenocortical suppression or impaired glycaemic control of diabetes mellitus, may occur also during

topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin, or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Due to the content of calcipotriol, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the maximum daily dose of Enstilar (15 g) is not exceeded. Enstilar contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. Skin on the face and genitals are very sensitive to corticosteroids. Enstilar should not be used in these areas. Instruct the patient in the correct use of the product to avoid application and accidental transfer to the face, mouth and eyes. Wash hands after each application to avoid accidental transfer to these areas. When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be discontinued. When treating psoriasis with topical corticosteroids, there may be a risk of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the posttreatment period. Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions. Treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid. There is no experience with the use of Enstilar in guttate psoriasis. During Enstilar treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks. Enstilar contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. Pregnancy and lactation: There are no adequate data from the use of Enstilar in pregnant women. Enstilar should only be used during pregnancy when the potential benefit justifies the potential risk. Caution should be exercised when prescribing Enstilar to women who breast-feed. The patient should be instructed not to use Enstilar on the breast when breast-feeding. Side effects: There are no common adverse reactions based on the clinical studies. The most frequently reported adverse reactions are application site

reactions. Uncommon (≥1/1,000 to <1/100): Folliculitis, hypersensitivity, hypercalcaemia, skin hypopigmentation, rebound effect, application site pruritus, application site irritation. Not known frequency: Hair colour changes. Calcipotriol: Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, psoriasis aggravated, photosensitivity and hypersensitivity reactions, including very rare cases of angioedema and facial oedema. Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria. Betamethasone (as dipropionate): Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis. Systemic reactions due to topical use of corticosteroids are rare in adults; however, they can be severe. Adrenocortical suppression, cataract, infections, impaired glycaemic control of diabetes mellitus, and increase of intra-ocular pressure can occur, especially after long-term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas, and during long-term treatment. Precautions for storage: Do not store above 30°C. Extremely flammable aerosol. Pressurised container. May burst if heated. Protect from sunlight. Do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on an open flame or other ignition source. Keep away from sparks/open flames. No smoking. Legal category: POM. Marketing authorisation number and holder: PA 1025/5/1. LEO Pharma A/S, Ballerup, Denmark. Last revised: May 2016 Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Cashel Road, Dublin 12, Ireland. e-mail: medical-info.ie@leo-pharma.com ® Registered trademark MAT-04853 Date of preparation: September 2016

Reporting of Suspected Adverse Reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie. Adverse events should also be reported to Drug Safety at LEO Pharma by calling +353 1 4908924 or e-mail medical-info.ie@leo-pharma.com

ALL LEO TRADEMARKS MENTIONED BELONG TO THE LEO GROUP

®

REPORT: Calls for a ¤1m cancer trial fund Page 12 CPD: A closer look at Gram Negative Page 27 AWARDS: The Winners of the 2016 Hospital Professional Awards Page 31 FEATURE: Focusing on Mental Health Page 47


3

HPN October 2016 Issue 31

Contents

Foreword

Ireland becomes first worldwide to trial new drug P6

Editor

Dublin hosts Biopharma Ambition Congress P8

Ireland has the clear potential to be a centre of international excellence. That was one of the key messages to come from the 2016 BioPharma Ambition Conference held over a weekend in Dublin last month (September).

Kelly Jo Eastwood

8

University Hospital Limerick Pharmacist talks Herceptin P14

The Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, representing the research based and manufacturing biopharmaceutical industries respectively, came together with the National Institute for BioProcessing Research and Training to host BioPharma Ambition®, a multi-platform event to inspire and showcase innovation.

Cyberknife Programme takes place at Hermitage Clinic P26 Hospital Professional Awards 2016 – The Winners P31

Mr Oliver O’Connor, Chief Executive Irish Pharmaceutical Association said the conference was an important event for both the biopharma industry and the island of Ireland as a whole.

26

Regulars Clinical Synopsis: ESCO Congress P16 31

Meanwhile in other news, the Irish Hospital Consultants Association (IHCA) has said that a blueprint for the next 10 to 15 years must outline the increased capacities in acute hospital, mental health and other services that will be in put in place each year to care for the current case load that presents to acute hospitals and for the projected increase in patient numbers.

Feature: Cardiovascular Disease P22 CPD: Gram Negative P27 Clinical R&D P54

47

Hospital Professional News is Circulated to all independent, multiple and hospital pharmacist, pre reg pharmacists, students pharmacy student’s offi cial bodies, government officials and departments, Pharmacy Managers, Manufactures, Wholesalers. Buyers of pharmacy groups and healthcare outlets. Circulation is free to all pharmacists Subscription rate for Hospital Pharmacy News ¤60 plus vat per year All rights reserved by Hospital Professional News. All material published in Hospital Professional News is copyright and no part of this magazine may be reproduced, stored in a retrieval system of transmitted in any form without written permission. Pharmacy Communication Ireland have taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

PUBLISHER IPN Communications Ireland Ltd Clifton House, Lower Fitzwilliam Street, Dublin 2 (01) 669 0562 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood kjeastwood@hotmail.com 00447876548989 ACCOUNTS Rachel Wilson cs.ipn@btconnect.com

“In order to grow the tangible benefits of the industry and life changing solutions we are calling on both Governments, North and South, to commit to developing the talent base across the island in order to meet future demands, grow both Ireland and Northern Ireland’s competitiveness globally, and provide greater support for clinical trials, IT investment and key specialists,” he said. Turn to page 8 for full coverage from the event.

COMMERCIAL MANAGER Sharon Kennedy Sharon@ipnirishpharmacynews.ie

Mobile: 0044 7765 236886 CONTRIBUTORS

Olivia Flynn | Dr Martin Cormican Dr Stephen McWilliams | C.P. Dunne C. O’Connor | M. Cormicanc T.W. Boo | E. McGrathd M.Commane | S. Mahony B. Slevin | A. O’Gorman E. O’Donovan | J. Powell R. Monahan | C. Finnegan M.G. Kiernan | J.C. Coffey L. Power | N.H. O’Connell

DESIGN DIRECTOR Ian Stoddart Design www.pharmacynewsireland.com www.facebook.com/ HospitalProfessionalNews

Speaking about the IHCA submission, Dr Tom Ryan, President of the IHCA said, “Appropriate governance together with proper resourcing are required to address the existing critical capacity constraints that are restricting the provision of timely, high quality healthcare to an increasing number of patients. To be successful, the long term plan and strategy must be properly resourced taking account of present and future anticipated levels of demand.” Lastly, this issue carries all the details from the 2016 Hospital Professional Award winners, which showcased the huge examples of excellence and innovation being carried out by Ireland’s hospital professionals. The fourth annual event saw over 400 of the country’s leading consultants, hospital pharmacists, clinical specialists, hospital CEO’s and Managers gather at the Hilton DoubleTree in Dublin to witness those who won 13 coveted titles ranging from Hospital Pharmacist of the Year to Consultant-Led Team of the Year. Turn to page 31 to view all this year’s winners.

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication HPN • October 2016


4 News

Outstanding Clinician Award for Professor Hoey Emeritus Professor Hilary Hoey was presented with the Outstanding Clinician Award at the 55th Annual Scientific Meeting of the European Society for Paediatric Endocrinology (ESPE). This is the first time that the award has been presented to an Irish physician. This prestigious award is in recognition of Professor Hoey’s outstanding leadership and contribution to the clinical practice of paediatric endocrinology, education and research in Europe and Internationally, in growth, diabetes, obesity and Down Syndrome. The Award was presented by Chairman of the ESPE Clinical Practice Committee, Professor Gary Butler, at the Annual Scientific Meeting in Paris, attended by over 3800 delegates. Professor Hoey thanked her colleagues across the world and in Ireland, in particular Professor Edna Roche of Trinity’s Department

Professor Hilary Hoey, Royal College of Physicians, Ireland

of Paediatrics and Head of the Department of Paediatric Diabetes and Endocrinology at the National Children’s Hospital Tallaght, and also her family for all of their help and support. Professor Hoey is Director of Professional Competence at the Royal College of Physicians of Ireland and Emeritus Professor of Paediatrics and Child Health Trinity College Dublin.

22nd Congress of the EAHP submit your abstract EAHP members are being reminded that abstracts for the 22nd Congress of the EAHP (2224 March 2017, Cannes) must be submitted by a deadline of close of Sunday 16th October 2016. A range of information about submitting abstracts is provided on the EAHP website, including: • the abstract review process;

• guidelines to assist those submitting abstracts for the first time; and

applicability, will be awarded with 3 prizes amounting to 750 euro, 500 euro and 250 euro.

• drug information and pharmacotherapy;

• tips on avoiding abstract rejection.

Abstract submissions from all disciplines of hospital pharmacy and related areas are welcomed, including, but not limited to:

• general Management;

Abstracts are limited to not more than 350 words. The best abstracts/posters, with regards to aspects like originality, scientific quality and practical

• clinical pharmacy;

• production and preparation;

• pharmacokinetics and pharmacodynamics; and, • patient safety and risk management.

• drug distribution;

Experts sought for EMA Advanced Therapy and Pediatric Committees The European Commission seeks to recruit new civil society representatives to the Committee for Advanced Therapies (CAT) and the Pediatric Committee (PDCO) of the European Medicines Agency (EMA). Interested hospital pharmacists are encouraged to apply before the respective deadlines of 30 September and 31 October. The Committee for Advanced Therapies (CAT) is the committee at the European Medicines October 2016 • HPN

Agency that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicinal products (ATMPs) and following scientific developments in the field. It is a multidisciplinary committee, gathering together some of the best available experts in Europe. Two members and two alternate members of the CAT are appointed by the European Commission to represent "clinicians", a definition of which

may be taken to include hospital pharmacists with practice expertise in the field. The Paediatric Committee (PDCO) is the committee at the European Medicines Agency that is responsible for assessing the content of paediatric investigation plans and adopting opinions on them. This includes assessing applications for full or partial waivers and assessing applications for deferrals.

Three members and three alternate members of the PDCO are appointed by the European Commission to represent healthcare professionals. More information about how to apply for the PDCO vacancies before the 31 October deadline is available by visiting the website of the European Association of Hospital Pharmacists at www.eahp.eu


5

Capacity extension critical to HSE – says IHCA The Irish Hospital Consultants Association (IHCA) has said that a blueprint for the next 10 to 15 years must outline the increased capacities in acute hospital, mental health and other services that will be in put in place each year to care for the current case load that presents to acute hospitals and for the projected increase in patient numbers. It said that the realistic resourcing of Ireland’s public hospital and mental health services must be prioritised if the country is to have a health service that can provide timely effective care to patients. Years of underfunding and a failure to account for demographic changes have resulted in a health service that has significant capacity, resource and physical infrastructure deficits. The IHCA highlighted these critical concerns in its submission to the Oireachtas Committee on the Future of Healthcare. The Association has also recommended that existing governance arrangements in the health service need to be strengthened significantly to be

fit for purpose and to enable the development of an integrated, effective and efficient health service in Ireland. Speaking about the IHCA submission, Dr Tom Ryan, President of the IHCA said, “Appropriate governance together with proper resourcing are required to address the existing critical capacity constraints that are restricting the provision of timely, high quality healthcare to an increasing number of patients. To be successful, the long term plan and strategy must be properly resourced taking account of present and future anticipated levels of demand.” The IHCA has questioned whether significant changes in the sources of funding for health care services, which are broadly similar to those used in other countries, are practical in the current economic situation or whether they would deliver sustainable benefits in terms of improved patient care given the risks in changing the model while substantial operational and service delivery issues and problems need to be addressed.

Dr Tom Ryan, IHCA President

Other recommendations by the IHCA include:  Realistic Resourcing: Realistic funding is required to end the under-resourcing of public hospital and mental health services that is preventing the delivery of timely care to patients. This must provide for the requirement to increase public hospital and mental health service capacities though increased investment to address the growing physical infrastructure, equipment and frontline staffing deficits.  Proper Planning and Demographic Pressures: Future resourcing must take full account of the existing unfunded and unmet patient care needs together with projected future demographic and other pressures which will increase the demand for care.  Universal Single Tier Health Service: A single tier health

system cannot be regarded as a healthcare end in itself, but must be viewed in the light of the health care benefit that will accrue from its implementation. The key challenge is to clarify and determine the scope, effectiveness and cost of the proposed universal single tier health service in contrast with the improved health service that would arise by addressing the priorities, challenges, roadblocks and deficits which are preventing the current health service from delivering timely, high quality care to patients.

Consultant’s Contract failure delays Arthritis Service 26,000 arthritis sufferers in Co. Mayo continue to be denied Rheumatology services despite an HSE commitment in July to provide a Consultant at University Hospital Castlebar. According to Independent MEP Marian Harkin this failure reflected the lack of urgency in the provision of services in the West and North West across a range of health issues. “A commitment has been made to provide a consultant who would travel from Manorhamilton hospital to Castlebar and this is long overdue response to the needs of Co. Mayo’s arthritis sufferers”, she said. “It is unacceptable that, at the beginning of October, a full year since interviews were held to appoint a consultant that the necessary contract has yet to be signed which would provide rheumatology service of 11 hours per week in Castlebar”, Marian Harkin said. She asked why, when a verbal confirmation of the consultants role had been given, that the contract had not been implemented. She continued, “For the service in Castlebar to be effective it requires not just a consultant but a multi-disciplinary support team to tackle the 2,500 people currently suffering on a waiting list. Having regard to the success of early intervention in treating arthritis and the huge extra cost involved to the state where late diagnosis and lack of treatment leads to 30% of people becoming disabled. The reality is that the sooner the patient is treated, the cost to the State is reduced.”

Dublin Midlands Group Chair steps down Dr Frank Dolphin has announced last month (September) that he is to step down as Chairperson of the Board of the Dublin Midlands Hospital Group (DMHG). Dr Dolphin has written to the Minister for Health informing him that he is unable to accept the Minister’s re-appointment to the role of Chair for the remainder of the term due to his increasing business commitments. Dr Dolphin has also informed the Heath

Service Executive (HSE) of his decision. Dr Dolphin has served across a range of senior roles in healthcare. A former Chairman of the HSE, he served as Chairperson of Temple Street Children’s Hospital and was appointed by Government to Chair the ministerial review group for the National Children’s Hospital. He was appointed Chairperson of DMHG in October 2013 and

played a key role in the successful establishment of the Group. The Group is a critical part of the wider healthcare reform agenda and is committed to providing highquality, safe patient care in the most cost-effective manner. Commenting, Dr Dolphin said, “I am pleased to have contributed to the Dublin Midlands Hospital Group. In a short timeframe, the Group has established itself on a firm footing, advancing key

reforms to enhance patient care and healthcare delivery across its seven hospitals. The Group is now moving to the next phase with a range of important measures to be advanced, not least developing the overall board. Given this, and my own time constraints, I believe now is the right for me to step away and let another person take on the mantle. I wish Dr Susan O’Reilly, the wider leadership team and my successor well.” HPN • October 2016


6 News

First patient worldwide to be treated with new drug in Ireland An Irish patient with the blood cancer ‘multiple myeloma’ has become the first in the world to take part in a new drug trial for patients with the disease who respond poorly to standard treatment.

Professor Michael O'Dwyer, Consultant Haematologist, University Hospital Galway

The clinical trial, looking at a new medicine called GMI-1271, is being run by Blood Cancer Network Ireland and has recently recruited its first patient in Beaumont Hospital, Dublin, under the supervision of Dr John Quinn, Consultant Haematologist and Associate Investigator with Blood Cancer Network Ireland. Blood Cancer Network Ireland is a ¤2.7 million cancer research and clinical trials initiative funded by the Irish Cancer Society and Science Foundation Ireland which brings together clinicians, scientists, and population health experts across Galway, Cork and Dublin with a shared interest in blood cancer research. The drug was first tested in Ireland, the US and Australia in patients with acute myeloid leukaemia and early results are very promising for treating patients with this form of blood cancer. Blood Cancer Network Ireland will now lead the way in evaluating whether the therapy is also effective in patients with multiple myeloma. Blood cancer is an umbrella term for cancers that affect the blood, bone marrow, and lymphatic system. Multiple myeloma is a cancer of the blood arising from a type of white blood cell which is called a plasma cell. Plasma cells normally produce antibodies which help fight infection. In myeloma the plasma cells become cancerous and are called myeloma cells. These can produce an excess of a single antibody which is harmful and stops the blood from working properly. In both acute myeloid leukaemia and multiple myeloma, some of the cancer cells can hide out in the bone marrow, where they stick to blood vessels, rendering chemotherapy less effective. This means that, even after chemotherapy has killed the majority of cancer cells, the cells in these ‘sanctuary sites’ survive and October 2016 • HPN

then go on to grow and multiply once again, causing the patient to relapse. If successful, GMI-1271 will prevent or delay this relapse. By testing the drug in tandem with standard chemotherapy, it is hoped that cancer cells will be unable to anchor themselves to the bone marrow, allowing chemotherapy treatment to kill all cancer cells in the patient. The opportunity to open the trial in Ireland is due to the research carried out by members of Blood Cancer Network Ireland and their strong collaboration with Glycomimetics, the biotechnology company which produced the drug. The GMI-1271 trial for multiple myeloma patients will also open in University Hospital Galway where Professor Michael O’Dwyer (Director of Blood Cancer Network Ireland) is leading the study. Commenting on the new trial, Professor O’Dwyer said, “This new clinical trial highlights the huge strides in cancer research and clinical trials which Blood Cancer Network Ireland has been a part of since our establishment in November 2015. “There are approximately 1,500 people in Ireland living with blood cancer. Blood cancers account for about 10% of cancer deaths and it is the relapsed drug resistant cancer that is the cause of most deaths. The fact that this new

trial provides hope for multiple myeloma patients is an exciting development that puts Blood Cancer Network Ireland at the forefront of blood cancer research on a global scale.” Consultant Haematologist at Beaumont Hospital, Dr John Quinn, joined Blood Cancer Network Ireland in February of this year after the Irish Cancer Society committed to an increased investment of ¤450,000 over the next five years to support the expansion of the network into Mater and Beaumont Hospitals. Speaking on his entry into the network, Dr Quinn said at the time, “We have been developing our clinical trial practice in haematology at Beaumont over the past five years, however, this major investment by the Irish Cancer Society will open up even greater access to blood cancer clinical trials and the latest treatments for our patients, and also strengthen the network as whole”. Head of Research at the Irish Cancer Society, Dr Robert O’Connor, welcomed this new Phase 1 clinical trial and praised the work of researchers linked to Blood Cancer Network Ireland. “The work being carried out by this country-wide network of clinicians, scientists, and population health experts highlights the importance of investing in such innovative and potentially life-changing cancer research,” he said.

We have been developing our clinical trial practice in haematology at Beaumont over the past five years, however, this major investment will open up even greater access to blood cancer clinical trials and the latest treatments for our patients, and also strengthen the network as whole.

“The Irish Cancer Society is proud to be partnering with Science Foundation Ireland on the funding of Blood Cancer Network Ireland, ensuring that Irish blood cancer patients benefit from the latest advances in cancer care and treatment.” Each year in Ireland approximately 250 people are diagnosed with multiple myeloma and 170 succumb to their disease. In the past a multiple myeloma diagnosis meant that a patient could only expect to survive for three to five years, with chemotherapy the only treatment available. Today, that average survival time has increased very significantly, and the introduction of new medicines in the coming years will likely see patient outcomes improve even further.


Taking life further in CLL

IMBRUVICA is indicated1 • As a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia • For the treatment of adult patients with: - chronic lymphocytic leukaemia who have received at least one prior therapy - relapsed or refractory mantle cell lymphoma - Waldenström’s macroglobulinaemia who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy

IMBRUVICA® 140 mg Hard Capsules PRESCRIBING INFORMATION ACTIVE INGREDIENT: Ibrutinib. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATIONS: Treatment of adult patients with: relapsed or refractory mantle cell lymphoma (MCL); chronic lymphocytic leukaemia (CLL) who are previously untreated or have received ≥ one prior therapy; Waldenström’s macroglobulinaemia (WM) who have received ≥ one prior therapy, or in first line in patients unsuitable for chemo-immunotherapy. DOSAGE & ADMINISTRATION: Adults: Orally, once daily, swallowed whole with water. MCL - 4 capsules. CLL & WM - 3 capsules. Concomitant moderate/ strong CYP3A4 inhibitors – reduce to 1 capsule (or, with strong inhibitors, withhold IMBRUVICA for up to 7 days). Withhold IMBRUVICA therapy for any new onset/worsening grade ≥ 3 nonhaematological toxicity, grade ≥ 3 neutropenia with infection/ fever, or grade 4 haematological toxicities. Re-initiate when toxicities resolved to grade 1 or baseline. If toxicities recur, reduce dose by 1-2 capsules. Discontinue IMBRUVICA if toxicities persist/recur following two dose reductions. Children: Safety/ efficacy not established ≤ 18 years old. Elderly: No dose adjustment required. Renal impairment: Mild/moderate - no dose adjustment. Severe – no data; consider benefit/risk and monitor closely. No data with dialysis. Hepatic impairment: Mild (Child-Pugh class A) – 2 capsules daily; moderate (ChildPugh class B) – 1 capsule daily; severe (Child-Pugh class C) – not recommended. Monitor for toxicities. Severe cardiac disease: No clinical data. CONTRAINDICATIONS: Hypersensitivity to active substance/excipients. St. John’s Wort preparations. SPECIAL WARNINGS & PRECAUTIONS: Bleeding-related events: Minor and major haemorrhagic events reported; caution with anticoagulant therapy – do not use concomitantly with warfarin or other vitamin K antagonists, avoid fish oil and vitamin E preparations. Withhold IMBRUVICA ≥ 3 to 7 days pre-/post-surgery. Leukostasis: Cases reported; consider temporary withhold of IMBRUVICA; monitor closely, give supportive care. Infections: Infections seen, some resulting in hospitalisation and death; monitor for fever, neutropenia and infections and give anti-infective therapy. Cytopenias: Treatment-emergent grade 3/4 cytopenias reported; monitor complete blood counts monthly. Atrial fibrillation/ flutter: reported particularly in patients with cardiac risk factors/ acute infections/previous history of atrial fibrillation; periodic clinical monitoring; consider ECG if arrhythmic symptoms or new onset dyspnoea develop; consider alternative to IMBRUVICA when pre-existing atrial fibrillation requiring anticoagulant

therapy or high risk of thromboembolic disease; where no suitable alternatives to IMBRUVICA, consider tightly controlled treatment with anticoagulants. Tumour lysis syndrome: cases reported. Monitor at risk patients closely, take precautions. Non-melanoma skin cancer: cases reported; monitor patients. Effects on the QT interval: mild decrease in QTcF interval seen; use clinical judgment before prescribing for patients at risk from further shortening QTc duration. Drug-drug interactions: Strong/ moderate CYP3A4 inhibitors may increase ibrutinib exposure; CYP3A4 inducers may decrease ibrutinib exposure. Avoid where possible, if not monitor closely for toxicities/lack of efficacy. SIDE EFFECTS: Very common: Pneumonia, upper respiratory tract infection, urinary tract infection, sinusitis, skin infection, neutropenia, thrombocytopenia, anaemia, dizziness, headache, haemorrhage, bruising, diarrhoea, vomiting, stomatitis, nausea, constipation, rash, arthralgia, musculoskeletal pain, pyrexia, oedema peripheral, muscle spasms. Common: Sepsis, nonmelanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, febrile neutropenia, leukocytosis, lymphocytosis, dehydration, hyperuricaemia, vision blurred, atrial fibrillation, subdural haematoma, epistaxis, petechiae, hypertension, dry mouth, erythema. Other side effects: Leukostasis syndrome, tumour lysis syndrome, hepatic failure, angioedema. Refer to SmPC for other side effects. PREGNANCY: Women of childbearing potential must use highly effective contraceptive measures during and for 3 months after stopping treatment; if using hormonal contraceptives, add barrier method. Not to be used during pregnancy. LACTATION: Discontinue breast-feeding during treatment. INTERACTIONS: CYP3A4 inhibitors: Strong: Avoid where possible or reduce dose (or withhold IMBRUVICA for ≤ 7 days) and monitor closely; e.g. ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazadone, cobicistat. Moderate: Avoid where possible or reduce dose and monitor closely; e.g. diltiazem, voriconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, fluconazole, fosamprenavir, imatinib, verapamil, amiodarone, dronedarone. Avoid grapefruit and Seville oranges. Mild: No dose adjustment required; monitor closely. CYP3A inducers: Strong/moderate: Avoid or monitor closely for lack of efficacy; e.g. carbamazepine, rifampicin, phenytoin. Mild: may be used; monitor for lack of efficacy. Medicines that increase stomach pH (e.g. proton pump inhibitors) may decrease ibrutinib exposure. Potential interactions: Oral narrow therapeutic range P-gp

or breast cancer resistance protein (BCRP) substrates (e.g. digoxin, methotrexate) should be taken ≥ 6 h before/after IMBRUVICA. Ibrutinib may inhibit BCRP in the liver and so increase exposure of drugs undergoing BCRP-mediated hepatic efflux (e.g. rosuvastatin). Ibrutinib may inhibit intestinal CYP3A4 and thus increase exposure of some CYP3A4 substrates sensitive to gut CYP3A metabolism; caution with narrow therapeutic range oral CYP3A4 substrates (e.g. dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus, tacrolimus). Ibrutinib is a weak CYP2B6 inducer and may affect expression of other enzymes and transporters regulated via the constitutive androstane receptor (CAR),(e.g. CYP2C9, CYP2C19, UGT1A1, MRP2). Exposure to substrates of CYP2B6 (e.g. efavirenz, bupropion) and co -regulated enzymes may be reduced with ibrutinib. Refer to SmPC for full details of interactions. LEGAL CATEGORY: Prescription only medicine PRESENTATIONS

PACK SIZES

MARKETING AUTHORISATION NUMBER(S)

Bottles

90 capsules

EU/1/14/945/001

Bottles

120 capsules

EU/1/14/945/002

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium FURTHER INFORMATION IS AVAILABLE FROM: JanssenCilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK. Prescribing information last revised: May 2016 Reference: 1. Imbruvica® Summary of Product Characteristics. Janssen Cilag International May 2016. Date of preparation: June 2016. PHIR/IBR/0616/0003 Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: medsafety@hpra.ie Adverse events should also be reported to Janssen-Cilag Limited on +44 1494 567447 or at dsafety@its.jnj.com

IMBRUVICA® is co-developed with Pharmacyclics. Janssen-Cilag Limited is the marketing authorisation holder and responsible editor of this document.

@JanssenIE © Pharmacyclics LLC 2016

Destination survival

© Janssen-Cilag Limited 2016


8 Conference

Potential is there to grow talent, competitiveness and innovation Pharmaceutical Industry has the potential to add thousands of jobs over the next three years, conference hears Dr Leisha Daly, President, IPHA, Mary Mitchell O'Connor, Minister of Jobs, Enterprise and Innovation and Keynote speaker Nigel Darby

Ireland has established itself as a place of global significance for the biopharmaceutical industry and capitalised on this by hosting a major international multi-function convention in Dublin on 21-22 September. The Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, representing the research based and manufacturing biopharmaceutical industries respectively, came together with the National Institute for BioProcessing Research and Training to host BioPharma Ambition®, a multi-platform event to inspire and showcase innovation. With international policy leaders, renowned researchers and senior industry personnel, the event highlighted the ambition of the industry for the health and well-being of populations. It demonstrated where the research is pointing and how Ireland will support innovation in discovery, development, manufacturing and healthcare solutions. Events took place in four locations across Dublin; Dublin Castle, Trinity Biosciences Institute, University College Dublin and Dublin City University. In addition, for the first time, the Massachusetts Institute of Technology’s (MIT) Hacking Medicine programme co-hosted a health hackathon in partnership with DCU Alpha the weekend prior to the main event. The 2016 BioPharma Ambition Conference Plenary Session was opened by Mary Mitchell O’Connor TD, Minister of Jobs, Enterprise and Innovation and Simon Hamilton MLA, Economy Minister of the Northern Ireland Executive. The plenary session features world leading industry experts from the pharmaceutical industry, which is worth over¤30 billion in exports and has the potential to add 8,000 jobs over the next three years[1] October 2016 • HPN

in Ireland and has the potential to double its size in Northern Ireland by generating revenues of £1.6 billion per annum by 2020[2]. In order to meet this ambition and realise the future full potential of the industry across the island of Ireland, North and South, the BioPharma Ambition Conference organisers, BioPharmaChem Ireland, the Irish Pharmaceutical Healthcare Association, the National Institute for Bioprocessing Research and Training have called for:  An emphasis on talent: invest in education and create a sustainable basis to fund excellence in STEM education particularly at university level in Northern Ireland and Ireland  Growth in competitiveness: focus on the fundamentals of a competitive business environment to facilitate the long term investment decisions made for bioprocessing  Growth in health innovation: ensure health services are capable of evaluating and bringing innovative medicines to patients quickly, by promoting more clinical trials and greater investment in IT and key specialists

The BioPharma Ambition Conference brings together international leaders from the US Food and Drug Administration, the UK’s National Institute for Health and Care Excellence and leading biopharma and medical researchers from MIT, the University of Pennsylvania, Queen’s University Belfast and Trinity College Dublin. Speaking on behalf of the 2016 BioPharma Ambition Conference organisers, Oliver O’Connor, Chief Executive Irish Pharmaceutical Association said the conference was an important event for both the biopharma industry and the island of Ireland as a whole. “There are clear opportunities for closer co-operation to make the island a centre of international excellence,” he said. “In order to grow the tangible benefits of the industry and life changing solutions we are calling on both Governments, North and South, to commit to developing the talent base across the island in order to meet future demands, grow both Ireland and Northern Ireland’s competitiveness globally, and provide greater support for clinical trials, IT investment and key specialists.”

IPHA Vice-President Ms Mary Dickens gave the opening remarks. As someone who has worked in the innovative biopharmaceutical industry both here and in the UK, Ms Dickens said she was ‘delighted to be attending this “showcase of discovery and adoption in healthcare” track of our very ambitious “Biopharma Ambition Convention” now underway across several locations in this City.’ She added, “The intent of these events in Dublin is clear from the title. What we are about is “ambition”, both in terms of what we do and what are striving to do as scientists, researchers, technicians and commercial leaders such as myself. “Though there is great diversity represented in the room here today, we are bound by a common goal – to achieve excellence in healthcare delivery. I can’t therefore think of a more apt place than here to be hosting this session focused on healthcare discovery. “The Trinity Biomedical Sciences Institute is a hotbed of innovation, drive and a ‘can do’ determination to foster scientific discoveries of biomedical importance.


ESMYA® (ULIPRISTAL ACETATE) TRANSFORMS THE MANAGEMENT OF UTERINE FIBROIDS ESMYA® is the first medical treatment for the long-term management of moderate to severe symptoms of uterine fibroids.1

PRESCRIBING INFORMATION Esmya (ulipristal acetate) Please refer to the SmPC before prescribing. Presentation: 5mg tablet. Indication: Pre-operative or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Dose and administration: One tablet of 5mg to be taken orally once a day for a maximum of 3 months, starting during first week of menstrual cycle. This 3 month treatment course can be repeated. Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion. Each treatment course should not exceed 3 months. Treatment free intervals are required between courses. Repeated intermittent treatment has been studied for up to 4 intermittent treatment courses. Please refer to SmPC for missed dose information. Patients with renal or hepatic impairment: No dose adjustment in mild to moderate renal impairment or mild hepatic impairment. Not recommended for patients with severe renal impairment and moderate or severe hepatic impairment unless patient is closely monitored. Children and adolescent under 18 years: No relevant use. Contraindications: Pregnancy, Breastfeeding, Genital bleeding of unknown aetiology. Uterine, Cervical, Ovarian or Breast cancer. Hypersensitivity to active substance or any excipients. Pregnancy and lactation: Contraindicated during pregnancy and lactation. Warnings and Precautions: Should only be prescribed after careful diagnosis and pregnancy should be precluded prior to treatment. Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended. Concomitant use of hormonal contraceptives are not recommended hence a non-hormonal contraceptive method should be used. Reversible histological changes of the endometrium: ‘Progesterone Receptor Modulator Associated Endometrial Changes’ (PAEC) may be observed in patients. Also, reversible thickening of the endometrium may occur during treatment. If it persists beyond 3 months following the end of treatment and return UK/ESM5/1015/0150a(1) August 2016

O

Licensed for intermittent use1

O

O

Fast, reliable and sustained control of bleeding2

Improved quality of life compared to baseline2

O

Well-tolerated2

O

Significant and sustained reductions in fibroid volume from baseline2

of menstruations, and/or an altered bleeding pattern is noted, this may need to be investigated as per usual clinical practice. Please refer to SmPC for further details on endometrial changes and management of the same. In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended. This includes an annual ultrasound to be performed after resumption of menstruation during off-treatment period. Treatment leads to significant reduction in menstrual blood loss within 10 days and patients should notify their physician if heavy bleeding persists. Drug interactions: Hormonal contraceptives and progestogens are likely to reduce the efficacy of ulipristal acetate by competitive action on progesterone receptors, hence co-administration is not recommended. Not recommended for patients receiving moderate or potent CYP3A4 inhibitors or potent CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St John’s wort). Co-administration of P-gp substrates (e.g. dabigatran etexilate, digoxin) should be separated in time by at least 1.5 hours. Undesirable effects: The following adverse reactions have been reported during first treatment courses: Very Common (≥1/10) Amenorrhea, Endometrial thickening; Common (≥1/100 to <1/10) Headache, Vertigo, Abdominal pain, Nausea, Acne, Musculoskeletal pain, Hot flush, Pelvic pain, Ovarian cyst, Breast tenderness/pain, Fatigue, Weight gain.; Uncommon (≥1/1000 to <1/100) Anxiety, Emotional disorder, Dizziness, Dry mouth, Constipation, Alopecia, Dry skin, Hyperhidrosis, Back pain, Urinary incontinence, Uterine haemorrhage, Metrorrhagia, Genital discharge, Breast discomfort, Oedema, Asthenia, Increase in cholesterol level Increased triglycerides, Rare (≥1/10,000 to <1/1,000) Epistaxis, Dyspepsia, Flatulence, Rupture of ovarian cyst, Breast swelling. When comparing repeated treatment courses, overall adverse reaction rates were less frequent in subsequent treatment courses than during the first one and each adverse reaction was less frequent or remained in the same frequency category (except dyspepsia which was classified as uncommon).

Overdose: Limited experience. Single doses of up to 200mg and daily doses of 50mg for 10 consecutive days administered to a limited number of subjects, and no severe or serious adverse reactions were reported. Special precautions for storage: Keep the blisters in the outer carton to protect from light. Legal Category: POM. Basic cost: €139.86 per pack of 28 tabs. Marketing Authorisation Numbers: EU/1/12/750/001, EU/1/12/750/002, EU/1/12/750/003, EU/1/12/750/004, EU/1/12/750/005. Marketing Authorisation Holder: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary. Further information is available from: Gedeon Richter UK Ltd, 127 Shirland Road, London W9 2EP, UK. Tel: +44 (0) 207 604 8806. Email: medinfo.uk@gedeonrichter.eu Date of Authorisation: 27th of May 2015. Date of Preparation: 4th August 2016. Adverse events should be reported to the HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, email: medsafety@hpra.ie. Adverse events should also be reported to Women’s Health Division of Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or drugsafety.uk@gedeonrichter.eu References 1. ESMYA® SmPC. 2. Donnez, J; Donnez, 0; Matule, D, et al. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril, 2016; 105(1):165-173.


10 Conference from industry. I would also of course like to acknowledge the support of SFI for “BioPharma Ambition” as a very valued sponsor.” Mary Mitchell O’Connor TD, Minister of Jobs, Enterprise and Innovation gave a talk on day two and stated, “This is an important event for the island of Ireland and one which highlights both the extensive level of BioPharma activity already taking place here and the future ambitions of the industry as a whole. Ireland is a recognised centre of excellence for the global biopharma industry. We are proud of that hard-won reputation but the Government remains focussed on working to support the continued growth of the sector in the country. We also want to help foster continued innovation in the industry that may lead not just to more job opportunities in Ireland but also to the development of new treatments that positively impact the lives of people all across the globe.”

Question and Answer Plenary Session

Northern Ireland Economy Minister Simon Hamilton MLA said, “The BioPharma area and broader Life and Health Sciences have been recognised by the Northern Ireland Executive as one of the priority sectors in helping to drive forward our economy, with growth of more than 20% in both turnover and employment over the past three years. Homegrown global leaders such as Almac Group, Norbrook and Randox, all headquartered in Northern Ireland and employing over 7,000 people, only serves to further underline the importance of the industry to our future economic growth. Mary Mitchell O’Connor TD, Minister of Jobs, Enterprise and Innovation and Simon Hamilton, NI Economy Minister

“When my own organisation, the Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, together with support from the National Institute for Bioprocessing Research and Training began to assemble a programme which would showcase the best of what Ireland has to offer in the in terms of biopharmaceutical and biomedical excellence, TBSI seemed an ideal platform for it. “TBSI’s focus is on outstanding discovery and an ambition to address unmet medical need for the treatment of diseases such as arthritis and Type 2 diabetes, motor neuron disease, multiple sclerosis, and different forms of cancer. “This Institute may be part of Ireland’s oldest University,

October 2016 • HPN

however, it is modern and forward looking. TBSI reflects the best of what it has to offer the world, and copper-fastens Trinity’s place as a leading international scientific university. “Central to much of what we will hear this afternoon is the role of Science Foundation Ireland. Through its Agenda 2020, it is developing a set of world leading large scale research centres that link scientists and engineers in partnerships across academia and industry. “As a representative of the biopharmaceutical industry, I certainly understand and greatly value what is being achieved through these SFI backed initiatives, where ¤335 million in Government funding is being bolstered by a further ¤190 million

“A climate which promotes partnerships between government, academia, clinical and private sectors in Northern Ireland has been central to this growth. If we are to sustain and, indeed, build upon this success, then the same spirit of collaboration will help develop new and innovative processes which will deliver, both in terms of prosperity and public health benefits.” Simon Harris TD, Minister for Health added, "The biopharma sector has made remarkable advances in medicines in recent years, developing new treatments that have been of huge benefit to patients. This conference sends a welcome signal that the industry is committed to making Ireland a real centre of excellence for biopharma - and to continuing its pursuit of new innovations that can transform the lives of patients in Ireland and elsewhere."

3R Creative Minds win first ever MIT Hacking Medicine event Ireland’s first world renowned Massachusetts Institute of Technology (MIT) ‘Hacking Medicine’ event sought to uncover treatment outcomes for patients. 3R, a post-stroke recovery and rehabilitation platform which through a userfriendly remote device application that guides, assists and monitors the rehabilitation of stroke victims in their own homes, beat off strong competition from eight other teams to claim the top spot. The team behind the project intend to meet with the relevant stakeholders including patient groups to see how the concept could be rolled out in the near future. Over 100 participants took part in the Hackathon organised in partnership with DCU Alpha as part of the Dublin 2016 International Biopharma Ambition Convention. The nine teams, were supported by 37 mentors from a variety of sectors including biopharma, health, technology, software and others, and worked throughout the weekend to develop solutions to provide patients with better treatment outcomes as well as specific areas such as better drug logistics and waste management, more effective doctor-patient interaction and a better overall patient experience. Other project ideas included:  Safe-Hands, a smart hand sanitising system which took second place overall in the competition; and  Sun, Sea & Surgery, a pan European bed shortage solution which took third place


News 11

Over 1million falsified or counterfeit medicines detained in 12 months The Health Products Regulatory Authority (HPRA) has published its annual report of key activities and performance highlights for 2015. The report details a successful year that has seen the HPRA complete its ambitious strategic plan (2011-2015) while prioritising its goal to protect public and animal health through the effective regulation of health products. During 2015, key elements and highlights included; • The approval of 108 clinical trials (80: 2014) for commencement in Ireland relevant to human medicines. The key clinical

research areas continue to be cancer and blood disorders. • The HPRA individually assessed and followed up 2,810 (2,884: 2014) adverse reaction reports in relation to human medicines in 2015. In addition, some 437 (300: 2014) suspected adverse reactions and events involving veterinary medicines were reported to and reviewed by the HPRA. • It opened 107 (116: 2014) compliance cases under its market surveillance programme for cosmetic products. These included 90 cosmetic

products deemed to be noncompliant with EU regulations. The breaches were mainly related to labelling, prohibited substances, contamination and/ or unsupported efficacy claims. • Over 2,126 (2,113: 2014) vigilance reports for medical devices were received. Each individual case was assessed to review risks and impact for the Irish market as well as to initiate follow-up actions as required. • The HPRA opened 3,677 (3,703: 2014) enforcement cases and detained over 1 million (1,136,494) dosage units of

medicines (730,056: 2014). Sedative products accounted for almost two-thirds (64%) of all detentions. Erectile dysfunction products and illegal cosmetic products accounted for 9% and 6% of detentions, respectively. According to Lorraine Nolan, Chief Executive, 2015 was a highly productive year where the HPRA as an organisation continued to clearly focus on its commitment to protect consumer and animal health through a risk-based regulatory approach.

First Space Shuttle Female Commander headlines Medical Council Conference The Medical Council is holding a Patient Safety & Leadership Conference in October and Astronaut Colonel Eileen Collins who was the first female to pilot and command an American space shuttle will be speaking at the event about the principles of teamwork, including the key factors for successful leadership on the day. In July 2005, Collins commanded Space Shuttle Discovery’s historic “Return to Flight” mission. This was NASA’s first manned flight following the February 2003 loss of the Shuttle Columbia. Columnist for the Times and author of two acclaimed books on the science of high performance,

Matthew Syed will also be speaking at the event. Syed’s first published book, Bounce, was printed in April 2010 and has been described as “one of the most intelligent and thoughtprovoking books about sport ever written” and Black Box Thinking, which was published in 2015, is a UK bestseller, and has been translated into multiple languages. Matthew Syed’s talent doesn’t stop there as he was also the England table tennis number one for almost a decade, three-times Commonwealth Champion, and twice competed for Great Britain in the Olympic Games (in Barcelona in 1992 and Sydney in 2000). Syed will be speaking about developing a ‘learning culture’ within a

working environment and how it can influence high performance teams. Delegates will be given an opportunity to further explore the topics discussed in a series of workshops, putting the themes into a real life context from a medical perspective. Commenting on the conference President of the Medical Council Professor Freddie Wood said, “I hope this will be an insightful and engaging day for all of those in attendance as these speakers are truly remarkable people who are absolutely passionate about leadership and high performance teamwork. Patient Safety is central to the role of the Medical Council

and we hope to continue to build upon our work in this area by collaborating with stakeholders in the health sector to ensure we are really driving home the key factors associated with upholding standards and minimising risk within the profession.” There will be 8 Continuing Professional Development (CPD) points will be awarded for attendance. The Conference will take place on Thursday, 27th October at the Radisson Blu Royal Hotel, Golden Lane. For more information on this, please go to the Medical Council’s website.

Cappagh National Orthopaedic Hospital opens new PACU Cappagh National Orthopaedic Hospital recently opened its new 12 bed Post Anaesthetic Care Unit (PACU) in Dublin. The Unit was opened by Minister for Health, Mr Simon Harris, T.D.

Ms Eve Linders Board Member Cappagh National Orthopaedic Hospital, Mr Simon Harris, Minister for Health, Mr Gordon Dunne CEO Cappagh National Orthopaedic and Mater Hospitals and Mr Keith Synnott Medical Board Chairman Cappagh National Orthopaedic Hospital

Mr Simon Harris, Minister for Health HPN • October 2016


12 Report

Calls made for a ¤1 million fund to boost cancer trials at a national policy level and promoted to all clinicians as a mainstream treatment option.

Eilbhlin Mulroe, CEO, ICORG

If we can get support for the initiatives in our submission we can save the State more in drugs costs, give patients more options not available through any other avenue and further develop our trials infrastructure. In its pre-Budget 2017 submission, Cancer Trials Ireland has called for the establishment of a ¤1million fund to enable cancer specialists open more cancer trials in Ireland.

can save the State more in drugs costs, give patients more options not available through any other avenue and further develop our trials infrastructure,” she said.

It has also called for a ring-fenced fund of ¤1.4 million within the HSE for the development of the existing 14 cancer trials research centres in hospitals* around the country.

There is the strong evidence to show that when cancer specialists such as oncologists have access to protected time they source and open more cancer trials in their areas of specialisation. The ¤1 million fund Cancer Trials Ireland is calling for would be available for oncologists for resources to support their cancer research. It suggests this fund could be administered by the National Cancer Control Programme or the Health Research Board.

Its submission argues that this investment in cancer trials will reduce the HSE’s cancer drug costs, provide people with cancer with access to promising treatments not normally available and attract more inward investment from pharmaceutical companies and international research organisations. Cancer Trials Ireland CEO, Eibhlin Mulroe, said that investing in Ireland’s cancer trials infrastructure made sense at a number of levels. “A recent independent report by DKM economic consultants** shows that for every ¤1 the Exchequer invests in cancer trials it saves more than ¤2 in cancer treatment costs. This year cancer trials will save the HSE more than ¤6.5 million in cancer drugs costs alone,” she said. “We are also able to multiply the impact of the Government’s investment in cancer trials by attracting investment from pharmaceutical companies and international research groups. In 2016 we will receive just over ¤3 million from the Exchequer and generate an additional ¤4.5 million from other sources. “If we can get support for the initiatives in our submission we

October 2016 • HPN

Cancer Trials Ireland has also called for a ring-fenced fund of ¤1.4 million within the HSE for capital and staff costs to bolster the existing network of cancer trials research units in the 14 hospitals around the country. It is seeking a once off allocation of ¤700,000 to upgrade existing research facilities, which in some instances are housed in temporary buildings, and ¤700,000 towards staff costs. This investment will enable Ireland’s cancer trials infrastructure better compete with facilities in other countries and encourage global pharmaceutical companies and international research organisations to open more cancer trails in Ireland. Mulroe added, “If the right research facilities are in place we can not only attract more valuable inward investment but we can offer cancer patients treatments which may otherwise only be available to patients in other countries.”

Meanwhile, Cancer Trials Ireland has called for a national health policy decision to mainstream cancer trials as a cancer treatment option for people with cancer. The call is included in its submission to The Oireachtas Committee on the Future of Healthcare. It also recommends that the pending National Cancer Strategy sets a target of 5% for the number of people diagnosed with cancer who participate in cancer drugs trial. The current participation rate is 3%. To exploit these opportunities the organisation recommends that Ireland’s national health policy commits to mainstreaming cancer trials in two ways. 1. Cancer Trials should be integrated into the National Cancer Control Programme

2. The opening of more cancer trials in Ireland by pharmaceutical companies and international collaborative research groups should be an objective integral to Ireland’s strategy to further develop its Life Science industry. Cancer trials will this year save the HSE more than ¤6.5 million in cancer drugs costs alone*. They will generate ¤4.5 million in inward investment, add a total of ¤16.5 million to Irish GDP per annum, and generate tax revenues for the Exchequer of ¤5.8 million per annum. * Cork University Hospital, Bon Secours, Cork, University Hospital Limerick, Midland Regional Hospital, Tullamore, University Hospital Galway,Sligo General Hospital, Letterkenny General Hospital, Waterford Regional Hospital, St Vincents University Hospital, Beaumont Hospital, St James’ University Hospital, Tallaght Hospital, Mater Misericordiae University Hospital and St Luke’s Hospital. ** Health and Economic Impacts of Cancer Trials in Ireland, DKM Economic Consultants (2016). (http://www.cancertrials.ie/newsevents/health-economic-impactreport-of-cancer-trials-in-ireland)


Prescribing Information (Ireland) ▼ Vargatef® 100 mg and 150 mg soft capsules Soft capsules containing 100 mg or 150 mg nintedanib (as esilate). Indication: Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after firstline chemotherapy. Dose and Administration: Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies. The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle. Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded. Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs. For posology, methods of administration, and dose modifications of docetaxel, please refer to the corresponding product information for docetaxel. Dose adjustments should be considered in case of adverse events of pre-specified severity: diarrhoea, vomiting, nausea and other non haematological or haematological adverse reactions, and aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and bilirubin elevations – as initial measure for the management of adverse reactions treatment with nintedanib should be temporarily interrupted. Please refer to the Summary of Product Characteristics (SPC) for further information including when to discontinue treatment. Paediatric population: Safety and efficacy in children aged 0-18 years have not been established. Elderly patients (≥ 65 years): No overall differences in safety and efficacy were observed for elderly patients. No adjustment of initial dosing required on the basis of a patient’s age. Race and body weight: Based on population pharmacokinetic analyses, no a priori dose adjustments necessary. Safety data for Black and African American patients are limited. Renal impairment: Less than 1 % of a single dose of nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy and pharmacokinetics have not been studied in patients with severe renal impairment (< 30 ml/min creatinine clearance). Hepatic impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). No adjustment of the starting dose is needed for patients with mild hepatic impairment based on clinical data (Child Pugh A). The safety and efficacy have not been investigated in patients with hepatic impairment classified as moderate (Child Pugh B) and severe (Child Pugh C). Treatment of patients with moderate to severe hepatic impairment is not recommended. The capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed. Contraindications: Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients. Warnings and Precautions: Patients with gastrointestinal disorders including diarrhoea, nausea and vomiting may require interruption, dose reduction or discontinuation of therapy. Diarrhoea should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide. Supportive care for nausea and vomiting may include medicinal products with anti-emetic properties, e.g. glucocorticoids, anti-histamines or 5-HT3 receptor antagonists and adequate hydration. In the event of dehydration, administration of electrolytes and fluids is required. Plasma levels of electrolytes should be monitored, if relevant gastrointestinal adverse events occur. Combination treatment with docetaxel is associated with a higher frequency of neutropenia of CTCAE grade ≥ 3 as compared to treatment with docetaxel alone. Subsequent complications such as sepsis or febrile neutropenia have been observed. Blood counts should be monitored during therapy, please refer to SPC. Hepatic function: treatment is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A). Nintedanib was associated with an elevation of liver enzymes (ALT, AST, ALKP, gamma-glutamyltransferase) or bilirubin, with a potentially higher risk for female patients. These increases were reversible in the majority of cases. Transaminase, ALKP and bilirubin levels should be investigated before initiation of combination treatment and monitoring continued as required. If relevant liver enzyme elevations are measured, interruption, dose reduction or discontinuation of the therapy with Vargatef may be required, please refer to the SPC. VEGFR inhibition might be associated with an increased risk of bleeding. Vargatef is not recommended in patients with recent pulmonary bleeding (> 2.5 ml of red blood) as well as patients with centrally located tumours with radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumours. Patients taking concomitant anticoagulation, such as warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, international normalized ratio (INR), and clinical bleeding episodes. Patients with stable brain metastasis should be closely monitored for signs and symptoms of cerebral bleeding. Treatment not recommended for patients with active brain metastasis. Patients should be closely monitored for thromboembolic events and Vargatef should be discontinued in patients with life-threatening venous thromboembolic reactions. Caution should be used when treating patients with a higher cardiovascular risk including known coronary artery disease. Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischaemia. Based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations. Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation. Treatment should only be initiated at least 4 weeks after major surgery. Therapy should be permanently discontinued in patients who develop gastrointestinal perforation. Nintedanib may impair wound healing. Treatment should therefore only be initiated or, in case of perioperative interruption, resumed based on clinical judgement of adequate wound healing. Caution should be exercised in patients who may develop QTc prolongation. Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations. Nintedanib exposure increased linearly with patient age, was inversely correlated to weight, and was generally higher in patients of Asian race which may result in a higher risk of developing liver enzyme elevations; close monitoring is recommended in patients with several of these risk factors. Close monitoring is recommended in patients weighing < 50 kg. Interactions: Interaction studies have only been performed in adults. P-glycoprotein (P-gp): Nintedanib is a substrate of P-gp. If co-administered, potent P-gp inhibitors e.g. ketoconazole or erythromycin may increase exposure to nintedanib. Patients should be monitored closely for tolerability of nintedanib. Potent P-gp inducers e.g. rifampicin, carbamazepine, phenytoin and St. John’s Wort may decrease exposure to nintedanib. Co-administration should be carefully considered. Cytochrome (CYP)- enzymes: Likelihood of drug-drug interactions with nintedanib based on CYP metabolism considered to be low. Other medicinal products: The potential for interactions with hormonal contraceptives was not explored. Fertility, Pregnancy and Lactation: Nintedanib may cause foetal harm in humans; women should avoid becoming pregnant while receiving this treatment and use adequate contraception during and for at least 3 months after the last dose of Vargatef. Since the effect of nintedanib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy. There is no information on the use of Vargatef in pregnant women, but pre-clinical studies have shown reproductive toxicity and therefore nintedanib should not be used during pregnancy unless the clinical condition requires treatment. Pregnancy testing should be conducted at least prior to treatment. Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy. If the patient becomes pregnant while receiving Vargatef, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Vargatef should be considered. There is no information on the excretion of nintedanib and its metabolites in human milk. Pre-clinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5 % of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Vargatef. Based on preclinical investigations there is no evidence for impairment of male fertility. There are no human or animal data on potential effects of nintedanib on female fertility available. Undesirable effects: The most frequently reported adverse reactions specific for nintedanib were diarrhoea, increased liver enzymes (ALT and AST) and vomiting. Very common (≥ 1/10): Neutropenia (includes febrile neutropenia), decreased appetite, electrolyte imbalance, peripheral neuropathy, bleeding, diarrhoea, vomiting, nausea, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, mucositis (including stomatitis), rash. Common (≥ 1/100 < 1/10): Febrile neutropenia, abscesses, sepsis, dehydration, venous thromboembolism, hypertension, hyperbilirubinaemia, gamma-glutamyltransferase increased. Prescribers should consult the Summary of Product Characteristics for further information on side effects and recommended measures. Pack sizes: 100 mg 120 capsules; 150mg 60 capsules. Legal category: POM. MA numbers: 100 mg: EU/1/14/954/002; 150 mg: EU/1/14/954/004. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Hyde Building, The Park, Carrickmines, Dublin 18. Prepared in September 2016

EXTENDING WHAT’S POSSIBLE VARGATEF®, the only triple angiokinase inhibitor for advanced adenocarcinoma of the lung after first-line chemotherapy1 VARGATEF® is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumour histology after first-line chemotherapy1

This medicinal product is subject to additional monitoring. Adverse events should be reported to the Health Products Regulatory Authority at www.hpra.ie or by email to medsafety@hpra.ie. Adverse events should also be reported to Boehringer Ingelheim Pharmacovigilance on 01 291 3960 or by email to PV_local_uk_ireland@boehringer-ingelheim.com

Reference: 1. VARGATEF® 100/150mg Summary of Product Characteristics. Available at: http://www.medicines.ie/medicine/16211. Accessed September 2016. IRE/VAR-161124a Date of preparation: September 2016


14 Case Study

Subcutaneous Trastuzumab for HER2-positive Breast Cancer – Evidence and Practical Experience A subcutaneous formulation of trastuzumab to treat patients with HER2-positive breast cancer has been available since August 2013. The subcutaneous formulation is administered as a fixed dose of 600 mg over a period of up to 5 minutes.

who has been using Herceptin Sub Cut (S/C) in her hospital setting since March, 2015.

Targeted anti-HER2 therapy with the monoclonal antibody trastuzumab (Herceptin®) is now the standard therapy for patients with early and with metastatic HER2-positive breast cancer. Patients with early-stage breast cancer receive trastuzumab as adjuvant therapy for a period of 1 year. For patients with metastatic breast cancer, treatment with trastuzumab is usually continued at least to disease progression or even beyond (treatment beyond progression).

“The first is to the patients, if the patient is not on intravenous (IV) chemotherapy at the same time, they do not require an intravenous line to be placed for drug administration. The time to administer sub-cutaneous (S/C) trastuzumab is significantly shorter than that of IV trastuzumab: five minutes versus 30 minutes.

Until recently, trastuzumab was administered intravenously only. Either in a three-weekly or in a weekly interval trastuzumab was adjusted to the patient's body weight. To allow a quick saturation of the HER2neu receptors treatment starts with a higher loading dose followed by a lower dose of trastuzumab to maintain the drug level. Since August 2013 a more time-saving subcutaneous (s. c.) formulation of trastuzumab is available to treat patients with HER2-positive breast cancer. Subcutaneous trastuzumab (Herceptin® SC) is administered as a fixed dose of 600 mg (irrespective of the patient's body weight) in a total fix volume of 5 ml. A loading dose is not required anymore. It is administered over a period of up to 5 minutes, while the time required for the intravenous infusion of trastuzumab is 90 minutes for the initial infusion and 30 minutes for each subsequent administration. The follow-up times are the same for both forms of administration.  Below, Hospital Professional News features a Case Study of the treatment in use locally. Case Study – University Hospital Limerick Olivia Flynn is a Chief II Pharmacist at the University Hospital Limerick,

October 2016 • HPN

“The benefits to using Herceptin Sub Cut (S/C) are for us, three-fold,” Olivia told Hospital Professional News.

“The second benefit it to the day ward with regards to time savings on patient cannulation and reduced drug administration times. Thirdly is the benefit to the Pharmacy aseptic compounding unit (ACU): Ŧtime savings on drug reconstitution. The intravenous product would take 10-15 minutes to prepare. The subcutaneous product takes about five minutes to prepare.” It was the nursing staff who firstly made the request to consider using subcutaneous trastuzumab within the hospital setting at University Hospital Limerick. Olivia continues, “Our initial challenge was the capacity of

our aseptic compounding unit. Up to that point, trastuzumab IV was outsourced. If the switch was to be made to trastuzuamb subcutaneous, the pharmacy ACU would have to reconstitute the drug on site, due to its limited shelf-life. “This would have a serious impact on an already very busy ACU. Another challenge was around deciding which patient groups would be suitable for the therapy.” The ACU team prepared a business case for prepared for an additional pharmacy technician. This business case also incorporated the increasing capacity experience in the ACU and was accepted. A new Pharmacy Technician was appointed, which allowed the team to proceed with switching to trastuzuamb subcutaneous. “The biggest challenge we have to using trastuzumab s/c in the ACU is its short expiry date,” says Olivia. “Once removed from the vial, the stability of trastuzumab in the syringe is 48 hours, under refrigeration. To facilitate workflow on our oncology day ward (ODW), trastuzumab doses have always been sent down to the day ward in advance of the patient presenting for treatment. With outsourced trastuzumab IV, there was a stability of 28 days, which facilitated advanced dispensing. “With the limited shelf life, if the trastuzumab s/c is prepared in advance there

is the risk that the dose could be wasted, which has significant cost implications. However, as there is flat dosing of 600mg, if one patient is not for treatment, there is the potential to use this dose for another patient later that day/ the next day. It is important to balance the risk of drug wastage against efficient work flow on the ODW.” Olivia continues, “In relation to the second challenge of deciding on which patient group should be switched to s/c, at University Hospital Limerick, it was decided to initiate all new patients on adjuvant treatment and metastatic treatment on trastuzumab s/c. Existing patients on adjuvant treatment would be given the option of switching from IV to s/c. Existing patients on treatment for metastatic disease would continue on IV treatment, unless they requested to have the route of administration changed to s/c.” Olivia believes a pre-filled device for trastuzumab subcutaneous is in the future treatment options for this group of patients. “This could facilitate patients self-administering treatment at home, once patients have been appropriately trained, or a public health nurse administering it to a patient in their own home or in their GP surgery,” she says. “I can see there being a significant increase in the number of oral agents becoming available, both cytotoxic agentsand targeted therapies. This will hopefully result in further lines of treatment being available to patients i.e. adjuvant treatment, metastatic treatment: 1st line, 2nd line, 3rd line, 4th line 5th line and so on. Hopefully these advances in therapy will result in patients living longer and with a better quality of life.


News 15

Pharmacist-led mental health programme Minister for Education and Skills Richard Bruton and Minister of State for Mental Health and Older People Helen McEntee has attended the launch of the Pharmacist-led Mental Health First Aid Ireland Training and Research Programme at the Royal College of Physicians held in Dublin. This programme has bespoke material available for pharmacists and so has been found to be very valuable training for pharmacists both in Ireland and Australia where it was originally developed. Mental Health First Aid is the initial help offered to a person who is developing a mental health problem, experiencing a worsening of an existing mental health problem or a mental health crisis. The first aid is given until appropriate professional support is received or until the crises resolves. Participants in the training programme learn how to recognise when someone is experiencing a mental health problem and through a framework of communication, how to offer and provide initial

Speakers at the launch. Fionuala Bonnar, Chief Operating Officer MHFA England, Poppy Jarman, Chief Executive MHFA England; Dolores Keating, Project Director MHFA Ireland; Donal Scanlan, Project Manager MHFA Ireland; Dr Kara McCann, Senior Labour Market Policy Executive, IBEC

help. They learn how to support a person to engage with appropriate professional care or other supportive help. For the first time in Ireland, Mental Health First Aid training is available to everyone via courses that are run throughout the country by Mental Health First Aid Ireland. There are also specifically tailored courses designed for corporate groups.

improving people’s confidence to provide help, increasing helping behaviours and reducing stigma. MHFA is included in the United States Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Evidencebased Programmes and Practices.

The Mental Health First Aid training programme has been extensively evaluated and found in research studies to be effective by improving mental health literacy,

Developed in Australia, MHFA is now being actively rolled out in 21 countries and over 1.5 million people have so far been trained in mental health first aid skills. MHFA

Prof Richard Blennerhassett, Clinical Director, Saint John of God Hospital (centre) and Mr Adrian Doherty, Saint John of God Hospital

Ireland, which is currently being supported by Saint John of God Hospital, aims to make MHFA training available throughout Ireland. Approximately one in 5 Irish people will experience a diagnosable mental health difficulty in any given year. Many people experience mental health problems for a long time before seeking help and don’t see that people can and do recover from a mental health problem.

Dolores Keating. MHFA Projector Director and Claire Murphy, Superintendent Pharmacist, Allcare

Ireland in official bid to host EMA Ireland is the latest country to put its name forward to host the European Medicines Agency (EMA), should it be relocated following the UK’s Brexit vote. Spain, Sweden, Denmark and Italy are among the other countries to have expressed interest in hosting the Agency, and the Irish Health Minister Simon Harris confirmed that his Government would be bidding to attract the EMA to Dublin. Mr Harris argued that a move across the Irish Sea would keep disruption to a minimum, and said that the excellent track record of the country’s Health Products Regulatory Authority (HPRA) and the part already played by many of its members on EMA committees, further strengthened his country’s case. Leisha Daly, President of the Irish Pharmaceutical Healthcare Association, is also backing the bid. “It makes sense, we’re an English speaking country and we have a huge pharma hub here," she said. "Even for the relocation of the staff, they probably could stay in the UK and work out of Dublin, we’re a 50-minute flight away.”

HPN • October 2016


16 Clinical Synopsis

European Society of Cardiology Scientific Programme The European Society of Cardiology brings together health care professionals from more than 120 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives. ESC Congress is the world’s largest gathering of cardiovascular professionals contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2016 took place 27 to 31 August at the Fiera di Roma in Rome, Italy. Below we feature some of the abstracts which featured in the scientific programme. Challenging Cases in Coronary Intervention: The Fast and The Furious Percutaneous treatment of a giant coronary aneurysm involving left main bifurcation and complex coronary stenosis Authors: J.F. Jayme Ferro1, A.P. Andrea Pacchioni1, C.P. Carlo Penzo1, T.U. Tomoyuki Umemoto1, R.T. Riccardo Turri1, A.F. Alfredo Fede1, B.R. Bernhard Reimers1, S.S. Salvatore Sacca1, 1Mirano Hospital, Cardiology - Mirano - Italy Topic(s): PCI / stents: devices and technique Citation: European Heart Journal (2016) 37 (Abstract Supplement), 1420 Coronary aneurysm (CA) is an uncommon disease with high risk of complications (rupture, ischemia from embolic events or thrombosis) especially if associated with coronary artery disease. A 83-year old woman was admitted for acute coronary syndrome (ACS) non ST-elevation. Medical hystory reported a subcritical bilateral carotid artery stenosis, a previous aortic abdominal aneurysmectomy, epatitis C virus infection, paroxysmal atrial fibrillation. A coronary angiogram showed diffuse 3 vessels disease: a giant coronary CA after a suboccluded distal left main (LM) (white arrow), followed by ostial disease and multiple aneurysmatic and stenotic lesions of the mid left anterior descending artery (LAD), an ostial lesions of the circumflex artery (CX), occluded in the middle tract; then a critical stenosis of the obtuse marginal branch (MO) and a proximal right coronary artery (RCA), chronically occluded, were detected (black arrow). After discussion with the Heart Team and according to the patient's will, endovascular treatment of the left coronary system was planned. A coronary computed tomography scan measured the CA around 23x16mm (Figure 2). Aim of our strategies was to treat first the aneurysmatic and stenotic lesions involving mid LAD, then to treat the MO lesions followed by LM bifurcation in order to embolize the giant CA.7 French XB guide catheter and transfemoral approach were used: (A) a standard 0.014 inch wire was inserted in LAD and a hydrophilic 0.014-inch wire crossed in the CX by looping into the CA; using anchoring technique and gently pulling back, this hydrophilic wire was straightened; predilatation and kissing with non-compliant balloon 3.5x20mm/2.5x20mm was performed. (B) Two self-apposing stents 3–3.5x27mm/3–3.5x22mm were deployed in the mid LAD. (C) MO was stented with an everolimus eluting stent 3.5x12mm, two other everolimus eluting stent 3.5x24mm/3.5x16mm (black arrow) fixed the LM-CX. (D) A standard 0.014 inch wire recrossed the stent struts in LAD, a hydrophilic wire recrossed the stent struts inside the CA;then a 45° preshaped microcatheter was placed in the CA and jailed over a drug eluting stent 3.5x26mm, deployed in the LM-LAD (Culotte Technique). (E) Six detachable coils (15mm x 57cm Complex Standard followed by 12mm x 45cm/11mm x 45cm/11mm x 45cm/9mm x 35cm/15mm x 45cm Complex Soft) were subsequently released. (F) Left main postexpansion with non-compliant balloon 4.5x20mm and kissing with non-compliant balloon 3.5x20mm/4x20mm were made. (G) Final angiogram showed left system stented, no residual flow in the CA. This case shows that treatment must be tailored according to the patient status and the anatomy of the CA. Stent-assisted coil embolization is a valuable strategy: keys points are the accurate planning of the procedure, the choice of stents, wires, microcatheter and coils. Medical therapy and follow up were managed respectly with a coronary angiogram at 6 month and triple antithrombotic therapy for 12 month. Successful percutaneous closure of a large circumflex coronary artery to coronary sinus fistula Authors: G. Ooues1, I. McCafferty2, J. De Giovanni1, P. Clift1, P. Calvert1, 1University Hospital Birmingham, Department of Cardiology Birmingham - United Kingdom, 2University Hospital Birmingham, Department of Interventional Radiology - Birmingham - United Kingdom, Topic(s): Non coronary cardiac interventions Citation: European Heart Journal (2016) 37 (Abstract Supplement), 1420-1421 A 61-year-old lady was referred with symptoms of angina and heart failure was found to have a huge coronary artery to coronary sinus fistula. Medical history included hypertension, atrial fibrillation (on warfarin), and breast cancer. Coronary angiography showed a large left main stem artery (14mm diameter) and an enlarged and highly tortuous circumflex artery (Cx), draining into the distal coronary sinus. The dominant right coronary artery (RCA) was unobstructed. Echocardiography showed moderate mitral regurgitation and elevated pulmonary arterial pressure (75mmHg). A percutaneous closure was initially attempted with a 22mm Amplatzer Vascular Plug II placed at the outflow end of the fistula. During the procedure, the device embolised to the left pulmonary artery, and was retrieved with a goose-neck snare and replaced with an 18mm muscular ventricular septal defect (VSD) device, with a stable end result. Four months post-procedure she had no symptomatic relief. Coronary computed tomography angiography demonstrated significant flow through the fistula. Exercise echocardiography confirmed inducible ischaemia in the LAD territory (coronary steal). Intravascular haemolytic anaemia developed due to high flow through the device. Repeat right and left heart catheterisation showed pulmonary hypertension, predominantly post capillary, a high cardiac output consistent with a large shunt and large flow through the device. October 2016 • HPN


Hospital Professional

Dynamic 100 Call for Nominations

HPN is seeking your nominations for the 2016 Hospital Professional Dynamic 100 The Professional Dynamic 100 is a unique look at the 100 key individuals, working within Hospital multidisciplinary teams, Hospital Pharmacy and the healthcare industry. The aim is to celebrate the most influential individuals in Irish hospitals today, recognises the contribution made by 100 key players in this fast changing arena. Inclusion in the Hospital Professional Dynamic 100 significantly is an acknowledgement of the expertise, unique capabilities and individual’s preeminent status for consistently enhancing healthcare within Ireland to enhance outcomes for colleagues, peers and the general public, the patients.  Who has inspired you this year?  Who deserves special recognition for an initiative or project completed this year?  Who has shown the ability to drive forward their profession? Nominations are being sought for individual contributions of excellence, innovation, best practice and progressive thinking in the Hospital sector. This may include (but is not limited to) CEO’s, Professors, Chief Pharmacist, Hospital Pharmacists, Consultants, Hospital Doctors, CEOs and Senior Management from Hospitals, Governing bodies and the Pharmaceutical Industry.

Please email your nominations to HPN Editor Kelly Jo Eastwood at kelly@ipnirishpharmacynews.ie before 10.11.2016


18 Clinical Synopsis She was turned down for surgical correction at multi-disciplinary meeting discussion, and repeat percutaneous closure of the fistula was performed, via the right femoral artery and vein. The device was approached from the arterial side using telescoping neuro-interventional guiding catheters (GC) (coronary GC were too short), guide-extension catheters and micro-catheters. A total of 13 x 60cm coils were nested on the arterial side of the muscular VSD device. This resulted in some slowing of the flow. Near complete occlusion was achieved using ethylene vinyl alcohol co-polymer, which is a liquid polymer that coagulates blood. Follow up at two months demonstrated complete symptom resolution and interval angiography confirmed closure of the fistula. Large coronary fistulae are rare but cause disabling symptoms and present a major therapeutic challenge. With careful planning and multidisciplinary team working, they can be effectively treated percutaneously. Much attention must be paid to the fistula's anatomy to prevent occlusion of branch arteries and warfarin must be used to prevent retrograde propagation of clot. Hybrid treatment approach of right atrial angiosarcoma Authors: J.C. Duarte Rodrigues1, R.C. Rui Cerqueira2, J.C.S. Joao Carlos Silva1, R.A.R. Rui Andre Rodrigues1, R.A. Rui Almeida1, P.B.A. Pedro Bernardo Almeida1, J.C. Jorge Casanova2, M.C. Manuel Campelo1, P.P. Paulo Pinho2, M.J.M. Maria Julia Maciel1, 1Sao Joao Hospital, Dept. of Cardiology - Porto - Portugal, 2Sao Joao Hospital, Dept. of Cardiothoracic Surgery - Porto - Portugal, Topic(s): PCI / stents: devices and technique Citation: European Heart Journal (2016) 37 (Abstract Supplement), 1421 Primary malignant cardiac tumors, such as angiosarcomas, are rare and usually fatal. The tumor is highly aggressive and locally invasive, it usually arises from the right atrium, with nonspecific symptoms and signs. As untreated, cardiac tumors have a poor prognosis, complete removal of the tumor and cardiac reconstruction is the mainstay of treatment and confers the best long-term outcome. We report the case of a 58-year-old male patient who presented to our hospital with complaints of shortness of breath on exertion, generalized weakness and fatigue for several weeks. The chest X-ray showed an increased cardiothoracic ratio. Further evaluation with transthoracic and transesophageal echocardiogram revealed a large mass occupying almost the entire severely dilated right atrium (RA), associated with a large pericardial effusion. Cardiac computed tomography (CT) angiogram confirmed the presence of a vascularized intramural mass originating from the RA free wall that widely invaded superior vena cava (SVC) and pericardium. Pericardiocentesis was inconclusive. Coronary angiography showed a large area of hypervascularized myocardium near the right ventricle projection that was supplied by the acute marginal branches of the right coronary artery. In order to minimize the blood loss caused by surgical trauma, we opted to perform embolization of the heart tumor, which was successfully accomplished using polyvinyl alcohol, platinum colis and a covered stent. Cardiac surgery included the excision of the mass, RA, SVC and inferior vena cava (IVC). The RA, SVC, and IVC were further reconstructed using bovine pericardium and a cardiovascular patch. The RA mass proved to be an angiosarcoma with resection margin clear on permanent pathology. The patient has been doing well five months after being discharged from the hospital and is currently undergoing adjuvant chemotherapy. Although primary cardiac tumors, namely angiosarcomas, are rare, complete surgical resection of the tumor is the most successful treatment for improving patients survival rate. In our patient, preoperative embolization of the tumor helped to control blood loss during tumor resection. To the best of our knowledge, this is the first reported case of a hybrid approach involving a endovascular treatment of a cardiac tumor followed by surgical tumor excision. Riddles in Inflammatory Heart Disease â&#x20AC;&#x201C; Who Needs Dr House? A first described case of cancer-associated non-bacterial thrombotic endocarditis on multiple valves in the era of novel oral anticoagulants Authors: F. Mantovani1, A. Navazio2, A. Barbieri3, G. Boriani3, 1Arcispedale Santa Maria Nuova - IRCCS, Department of Cardiology - Reggio Emilia - Italy, 2Ospedale Civile di Guastalla, Department of Cardiology - Reggio Emilia - Italy, 3Polyclinic Hospital, Department of Cardiology Modena - Italy Topic(s): Endocarditis Citation: European Heart Journal (2016) 37 (Abstract Supplement), 1414 A 65-year-old woman presented to emergency room, with progressive shortness of breath. She had a pulmonary embolism 3 months earlier, with evidence of lower extremity deep vein thrombosis, in current treatment with NOAC (Rivaroxaban 20 mg o.d.). Blood results showed an increased D-dimer level (12 690 ng/ml) and a thoracic angio-CT was done to rule out a recurrence of pulmonary embolism in spite the anticoagulation regimen, resulted in no pathological findings. The ECG was unremarkable but high sensitivity of troponin-I was positive at 0.9 ng/L without any clinical features of myocardial ischaemia. To investigate the patient's symptoms, a transthoracic echocardiogram was performed. Echocardiogram showed severe aortic and mitral regurgitation, not previously reported. A transesophageal echocardiogram (TOE) was performed with the evidence of multiple and highly mobile vegetations on atrial sides of the mitral valve leaflets and attached to the ventricular surface of the aortic valve. There were no stigmata of infective endocarditis since she was afebrile, without leukocytosis or positive blood cultures. Giving the high mobility of valvular vegetations a cerebral and abdominal CT scan was urgently performed with evidence of right occipital focal hypodense area and disomogeneus multiple lesions of the pancreatic gland highly suggestive for neoplastic process. Therefore among non-infectious aetiologies of the cardiac lesions, non-bacterial thrombotic endocarditis (NBTE) was the definitive diagnosis. Hypercoagulable state derived from pancreatic cancer and causing NBTE was assessed and monitored using the disseminated intravascular coagulation (DIC) score. Initial patient's DIC score was 3. Therapy with Rivaroxaban was withdrawn, and intravenous unfractioned heparin (UFH) was started in order to reduce thrombus size and the incidence of thromboembolic events in NBTE. Intravenous diuretics were administered to relieve pulmonary congestion. TOE was repeated 5 days later showed a nearly complete resolution of mitral regurgitation with tiny residual vegetation, while no changes were showed on aortic valve. DIC score passed from 3 to 0. Patient symptoms ameliorated and the patient was discharged on subcutaneous enoxaparin (8000 U S.C. b.i.d.) and underwent her oncologic work-up. At one-month follow-up no progression of valvular disease was documented. She died 3 months later for cancer related non-cardiac complications. Of interest, there is no evidence in literature on NOAC use in cancer related hypercoagulable state. In this clinical case the patient had a non-bacterial thrombotic endocarditis during treatment correctly assumed with Rivaroxaban while switching to unfractioned heparin seemed to partially resolve valvular dysfunctions, raising questions on the best pharmacological strategy in treating thrombosis in cancer patients, a population usually excluded from randomised trials. October 2016 â&#x20AC;˘ HPN


19 Right-sided heart failure: the key is to the x-ray Authors: N. Rojo Prieto1, I. Blanco Martinez1, V. Alonso Fernandez1, C. Lezcano Pertejo1, L. Romero Roche1, M. Rodriguez-Santamarta1, R. Estevez-Loureiro1, F. Fernandez-Vazquez1, J. Gualis Cardona2, M. Castano Ruiz2, 1Hospital of Leon, Cardiology Department - Leon - Spain, 2Hospital of Leon, Cardiovascular Surgery Department - Leon - Spain Topic(s): Acute cardiac care in the emergency department Citation: European Heart Journal ( 2016 ) 37 ( Abstract Supplement ), 1415-1416 A 33-year-old man was admitted to our Institution. He complained of abdominal fullness, progresive edema of lower limbs, as well as asthenia. He also referred decreased urine output. Relevant medical data included being native to Morocco, tobacco and drug abuse, and a period of one week hospitalization the previous month due to bilateral pneumonia of unknown ethiology. Physical examination revealed high jugular venous pressure with paradoxical rise on inspiration period (Kussmaul's sign) and hepatojugular reflex. Cardiac auscultation exhibited muffled heart sounds and a remarkable pericardial knock. A three centimeter painful hepatomegaly was demonstrated, as well as a noteworthy leg pitting edema. Being the syndromic diagnosis of right-sided heart failure already established, diuretic therapy was prescribed with a spectacular response and relieve in symptoms. After stabilization, the patient underwent further complementary testing. Analyses revealed slight anaemia and hyperuricemia. An electrocardiogram showed findings compatible with both atria enlargement and left ventricle overload. A chest X-ray displayed an enlarged heart silhouette and calcification of both layers of pericardium. This was confirmed on CT-scan. An echocardiogram at bedside showed data suggestive of constrictive-effusive pericarditis. Cardiac catheterization revealed equalization of right and left ventricular diastolic pressures with elevation of filling pressures. Due to the coincidence of a lung infection and a constrictive pericarditis one month afterwards, a complete screening for tuberculosis infection was deemed suitable, including tuberculin skin test and interferon-gamma release assays, being repetitively negative. He was intended for cardiac surgery. A subtotal pericardiectomy (from phrenic nerve to phrenic nerve) was performed. Disappearance of symptoms was proved. Notwithstanding, etiology of the pericardial constriction could not be cleared up. Loeffler's endocarditis presenting with atrial flutter and acute heart failure in patient affected by Churg Strauss syndrome Authors: D. Sirico1, E. Ammirati1, M. Cipriani1, A. Garascia1, P. Pedrotti1, G. Masciocco1, J. Schroeder2, E. Bonacina3, C. Giannattasio1, M. Frigerio1, 1Niguarda Ca' Granda Hospital, Dipartimento Cardiotoracovascolare &#x201C;A. De Gasperis&#x201D; - Milan - Italy, 2Niguarda Ca' Granda Hospital, Dipartimento di Allergologia ed Immunologia - Milan - Italy, 3Niguarda Ca' Granda Hospital, Dipartimento di Anatomia Istologia Patologica e Citogenetica - Milan - Italy Topic(s): Acute intensive cardiovascular care Citation: European Heart Journal ( 2016 ) 37 ( Abstract Supplement ), 1416 Introduction: Loeffler's endocarditis (LE) is a rare condition, characterized by eosinophilic myocarditis, endomyocardial fibrosis, cardiac thromboembolism and heart failure. Case report: A 65-year-old male presented with palpitations and dyspnoea. He reported a history of hypertension, active smoking, juvenile asthma, surgically treated nasal polyposis. Vital signs were: blood pressure 115/90 mmHg; heart rate140 bpm; saturations 96% on room air. ECG showed atrial flutter 2:1. Chest X-ray demonstrated interstitial-alveolar stasis. Laboratory tests at admission revealed normal leukocyte count (8620/mm3), with eosinophilia (18%), INR 1.62, creatinine 1.4 mg/dl, bilirubin 1.53 mg/dl, NT-proBNP 2641 ng/L, Hs Troponin T 32.9 ng/L. 2D-echocardiography demonstrated a left ventricle (LV) of normal size, depressed ejection fraction (LVEF 26%), restrictive LV filling pattern, and apical obliteration possibly caused by stratified thrombus. Right ventricular dilation and hypokinesia, mitral and tricuspid moderate- to-severe regurgitation, and severe biatrial dilation were also detected. The patient was treated with intravenous (iv) furosemide, digoxin, beta-blockers and LMWH. Cardiac magnetic resonance (CMR) confirmed biventricular hypokinesia with apical obliteration, biatrial dilation, and atrioventricular valves regurgitation. Marked biventricular endocardial late gadolinium enhancement with apical contrast-free areas, consistent with endomyocardial extensive fibrosis and apical thrombosis was identified. Detailed review of prior medical records revealed chronic prednisone treatment until nasal polyps removal five years before, and few months after surgery, and after steroids discontinuation, an hospitalization for interstitial/multifocal and culture-negative “pneumonia”. On these basis, Churg-Strauss Syndrome (CSS) and cardiac involvement as LE, with prior “pneumonia” as probable lung manifestation of the same disease, was suspected. Further laboratory testing showed elevated eosinophilic cationic protein and total IgE. Right ventricular endomyocardial biopsy was attempted, however endomyocardial surface was unusually “hard”, and no diagnostic material was collected. Prednisone 50 mg/day and Cyclophosphamide were started, with quick eosinophil count normalization. After 3 weeks, 2D-echocardiography showed a partially improved LVEF to 35%. Discussion: LE has been rarely described in association with CSS. Our case is peculiar due to advanced stage and phenotype (atrial flutter, acute heart failure and biventricular thrombosis) at clinical diagnosis. The diagnostic gold standard of LE remains endomyocardial biopsy (EMB), but in this case advanced fibrosis, with marked biventricular endocardial thickening, impeded adequate tissue sampling. Diagnosis was established by recollecting and reinterpreting detailed patient history in light of imaging findings, especially CMR, and confirmed by partial improvement of cardiac contractility after reinstitution of steroidal therapy.

Nightmares in the Cath Lab Embolized AMPLATZER septal occluder: what now? Authors: J.C. Duarte Rodrigues1, S.M.L. Sergio Machado Leite1, J.C.S. Joao Carlos Silva1, R.A.R. Rui Andre Rodrigues1, R.A. Rui Almeida1, P.B.A. Pedro Bernardo Almeida1, J.C. Jorge Casanova2, M.C. Manuel Campelo1, P.P. Paulo Pinho2, M.J.M. Maria Julia Maciel1, 1Sao Joao Hospital, Dept. of Cardiology - Porto - Portugal, 2Sao Joao Hospital, Dept. of Cardiothoracic Surgery - Porto - Portugal Topic(s): Non coronary cardiac interventions Citation: European Heart Journal ( 2016 ) 37 ( Abstract Supplement ), 1423-1424 The secundum type atrial septal defect (ASD) is a common congenital heart defect with an incidence corresponding to 5.9% of diagnosed congenital heart disease. Even though surgery is the gold standard, percutaneous device closure is gaining popularity because of its efficacy and relative safety. The use of AMPLATZER Septal Occluder has yielded excellent results in properly selected patients. Although rare, there are potentially severe complications such as device embolization after deployment. We report the case of a 53-year-old woman with a secundum ASD in whom percutaneous device closure was proposed. The procedure was taken under fluoroscopic and echocardiographic guidance and was successfully held. But, a few hours later the patient developed acute shortness of breath and palpitations. An transthoracic echocardiography was performed and showed a embolized AMPLATZER to the left ventricle (LV). Without delay, percutaneous retrieval of the device was attempted: through a right femoral venous access, a 10F sheath Swan-Ganz catheter provided with a snare was introduced witch then passed to the LV through the ASD and, because stabilizing the device before retrieval is very important, through the left femoral arterial access a guidewire with a 6F pigtail catheter was also placed. After several unsuccessful attempts with increasingly larger snares the patient began with chest discomfort and systolic blood pressure dropped to 80 mmHg. Coronary angiography was immediately performed and showed a left coronary artery with no lesions and air in the right coronary artery due to rupture of the Swan-Ganz balloon. There was a rapidly clinical improvement and hemodynamic stabilization. The patient underwent urgent standard cardiac surgery for device extraction and the ASD was repaired with autologous pericardium with an uneventful postoperative course.

HPN • October 2016


20 News

Future of Healthcare - eHealth Ireland Richard Corbridge, HSE Chief Information Officer and eHealth Chief Executive and Yvonne Goff, HSE Chief Clinical Information Officer recently attended the Oireachtas Committee on The Future of Healthcare. The main focus of this committee was to hear about the progression in the last 18 months of eHealth Ireland. The eHealth Ireland team has thus far met all of the targets set in plan in the spring 2015. The success of 2015 has released a small amount of additional funding to the HSE in this area after over a decade of what is considered to be underinvestment. Richard Corbridge pointed out that the work being done in Ireland around clinical engagement has been recognised by the European Union, the World Health Organisation and the NHS as having world class clinical engagement and leadership in many of its digital projects. Corbridge explained that by “No more IT projects” he wants to focus more on business change than the technology. Digital solutions can be seen as a catalyst to the delivery of integrated and personalised care, they are immune to organisational structure

Richard Corbridge, HSE Chief Information Officer and Yvonne Goff, HSE Chief Clinical Information Officer

and change. They are put in place to empower the patient to choose where they want to be treated and to neutralise the current boundaries of health care. During 2016 eHealth Ireland focused on a number of national solutions that can become the foundational elements for the future of a digital fabric of Ireland. One of these projects is individual health identifier (IHI), which will be soon connected to the first local health system, joining up information and supporting integrated care. The technology infrastructure to support the individual health identifier is completed. The HSE is ready to place the individual health identifier on all electronic referrals as soon as the Department has completed this negotiation. Other major project is the National Electronic Referral programme. Implementation of electronic referrals in every hospital in Ireland is completed.

More than 40% of GPs used the service in August 2016, with 10,733 referrals being handled by this digital service during that month.

All of these projects are part of a ten-year programme that will put in place a set of solutions built around the individual health identifier.

Other key projects that will deliver benefits before the end of this year are the first national digital health record MNCMS (maternity and newborn clinical management system), MedLIS (single digital lab system) and connectivity of delivery staff to digital solutions.

It is expected that by 2020, clinicians will be able to access digital information about patients appropriately, and by 2025 we will see a digital fabric throughout the health system including a system that is also accessible and in the hands of the people of Ireland.

Chemotherapy Combination with Capecitabine extends Survival A European phase III trial, one of the largest ever conducted in pancreatic cancer has shown that adding the oral drug capecitabine chemotherapy to gemcitabine prolongs survival without increased toxicity. Adjuvant gemcitabine chemotherapy is currently the standard of care worldwide after surgical removal of pancreatic cancer. The study was recently presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. “Unfortunately, most patients are not candidates for surgery when they are diagnosed with pancreatic cancer,” said lead study author John P. Neoptolemos, MA, MB, BChir, MD, FMedSci, the chair of surgery in the Department Molecular and Clinical Cancer Medicine at the University of Liverpool in Liverpool, United Kingdom. “These findings are significant because they show that those patients who can undergo

October 2016 • HPN

surgery have a fighting chance of surviving this cancer with the combination of two commonly used chemotherapies.” With 732 patients, the European Study Group for Pancreatic Cancer (ESPAC) 4 trial is the second-­ largest clinical trial ever conducted in patients with pancreatic cancer who had undergone surgery. Within 12 weeks of surgery, patients with early-­stage pancreatic ductal adenocarcinoma were randomly assigned to receive either gemcitabine alone or gemcitabine with capecitabine for 24 weeks. Key Findings The median overall survival was 28.0 months with the combination regimen vs. 25.5 months with gemcitabine alone. The estimated 5-year survival rates were 28.8% vs. 16.3% in the two groups. “The difference in median survival may seem modest, but the improvement in long-term survival

is substantial for this cancer,” said Dr Neoptolemos. “We’ve gone from a five-year survival rate of 8% with surgery alone to nearly 30% with adjuvant therapy.” According to the authors, the patient characteristics were representative of a real-world pancreatic cancer population. A large proportion of patients had unfavourable prognostic factors, such as locally advanced or aggressive disease, large tumour size, or incomplete removal of the tumour. The survival advantage with the combination regimen was similar irrespective of such factors. Patients who had been smokers but stopped smoking after their diagnosis had better outcomes than those who continued smoking. Overall, there were no major differences in the types and severity of side effects between the two groups. Severe diarrhoea

was slightly more common with the combination regimen (14 vs. 5 patients), as was fatigue (16 vs. 14 patients). Quality of life was also comparable between the two groups. The safety of this new gemcitabine - capecitabine chemotherapy regimen opens the opportunity to add other treatments to this combination, which might further improve outcomes for patients. Future research efforts will focus on developing tests to predict which patients would benefit most from a particular adjuvant therapy. Pancreatic cancer is not a common cancer. In Ireland about 370 people are diagnosed with it each year. But it is likely to increase in future years due to lifestyle changes. Most cases occur in adults over the age of 60. - See more at: https://www.cancer. ie/cancer-information/pancreaticcancer/about#sthash.IBWPWb2m. dpuf


ONCOLOGY Gemcitabine 38 mg/ml Ethanol Free

Gemcitabine 38 mg/ml TRUSTED GENERICS: TOTAL CARE Store below 25˚C. Do not refrigerate. Do not freeze.

Ethanol Free

Store below 25˚C. Do not refrigerate. Do not freeze.

Locally advanced or metastatic TRUSTED GENERICS: TOTAL CARE bladder cancer

C

C

M

M

Y

Y

C MC

C MC

M YM

M YM

Y YC

Y YC

MC YMC

MC YMC

YM K

YM K

YC

YC

YMC

YMC

K

K

Locally advanced or metastatic Locally advanced or metastatic adenocarcinoma of the pancreas bladder cancer First line treatment of locally Locally advanced or metastatic advanced or metastatic NSCLC adenocarcinoma of the pancreas Locally advanced or First line treatment of locally metastatic epithelial ovarian advanced or metastatic NSCLC carcinoma Locally advanced or Unresectable locally recurrent metastatic epithelial ovarian or metastatic breast cancer carcinoma Unresectable locally recurrent or metastatic breast cancer Gemcitabine Kabi 200 mg/5.26ml .26 ml Gemcitabine Kabi 1000 mg/26.3ml 26.3 ml 200 mg/5.26ml .26 ml 52.6 ml 2000 mg/52.6ml 1000 mg/26.3ml 26.3 ml 2000 mg/52.6ml 52.6 ml

Prescribing Information Consult the Summary of Product Characteristics for full information. Additional information is available on request. Gemcitabine 38 mg/ml concentrate for solution for infusion. Active ingredients: gemcitabine hydrochloride, equivalent to 38 mg gemcitabine/ml.Excipients include sodium hydroxide and propylene glycol. Indications: Locally advanced or metastatic bladder cancer in combination with cisplatin. Locally advanced or metastatic adenocarcinoma of the pancreas. Consult SPC for additional indications for use. First line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin. Gemcitabine monotherapy considered in elderly or performance status 2 patients. Locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. In combination with paclitaxel, in unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Dosage and administration: Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Bladder cancer, combination use: 1,000 mg/m2, given by 30-minute infusion. Dose on days 1, 8 and 15 of each 28-day cycle in combination with cisplatin. Cisplatin dose 70 mg/m2 on day 1 following gemcitabine or Day 2 of each 28-day cycle. This 4-week cycle is then repeated. Pancreatic cancer: 1,000 mg/m2, given by 30-minute intravenous infusion. Repeat once weekly for up to 7 weeks followed by a week of rest. Subsequent cycles of injections once weekly for 3 consecutive weeks out of every 4 weeks. See SPC for dosages in other indications. NSCLC monotherapy: 1,000 mg/m2, given by 30-minute intravenous infusion. Repeat once weekly for 3 weeks, followed by a 1-week rest period. This 4-week cycle is then repeated. NSCLC combination use: 1,250 mg/m2 body surface area given as a 30-minute intravenous infusion on Day 1 and 8 of the treatment cycle (21 days). Cisplatin has been used at doses between 75 - 100 mg/m2 once every 3 weeks. Breast cancer, combination use: Paclitaxel (175 mg/m2) administered on Day 1 over approximately 3 hours as an intravenous infusion, followed by gemcitabine (1,250 mg/m2) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-Day cycle. Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) prior to initiation of gemcitabine + paclitaxel combination. Ovarian cancer, combination use: Gemcitabine 1000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30-minute intravenous infusion. After gemcitabine, carboplatin will be given on Day 1 consistent with a target AUC of 4.0 mg/ml·min. Dose modification due to haematological toxicity dependant on platelet and granulocyte counts – see SPC for detail. Use with caution in renal or hepatic impairment; not recommended in children under 18yrs. Contraindications: Hypersensitivity to the active substance or excipients, breast-feeding. Special Warnings and precautions (See SPC for full details) for use: Prolongation of infusion time and increased dosing frequency increases toxicity. Haematological toxicity.: Suppression of bone marrow function as manifested by leucopaenia, thrombocytopaenia and anaemia. Patients should be monitored prior to each dose for platelet, leucocyte and granulocyte counts. Suspension or modification of therapy when drug-induced bone marrow depression is detected. Peripheral blood counts may continue to deteriorate after gemcitabine has stopped. In patients with impaired bone marrow function, treatment should be started with caution. The risk of cumulative bone-marrow suppression considered when given together with other chemotherapy., Hepatic and renal impairment.Concomitant radiotherapy given together or ≤ 7 days apart - toxicity reported. Live vaccinations not recommended. Posterior reversible encephalopathy syndrome. Caution in patients with a history of cardiovascular events. Capillary leak syndrome reported when receiving gemcitabine as single agent or in combination with other chemotherapeutic agents. Pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS) have been reported - consider discontinuation of therapy. Renal: Haemolytic Uraemic Syndrome. Fertility: Men advised not to father a child during and up to 6 months after treatment. Interactions: Consult SPC for detailed information on interactions. Fertility, pregnancy, lactation: not recommended, see SPC. Undesirable effects: Very common: Leucopaenia, thrombocytopaenia, anaemia, dyspnoea, vomiting, nausea, elevation of liver transaminases (AST and ALT) and alkaline phosphatise, allergic skin rash frequently associated with pruritus, alopecia, haematuria, mild proteinuria, influenza-like symptoms, oedema/peripheral oedema. Common: Febrile neutropaenia, anorexia, headache, insomnia, somnolence, cough, rhinitis, diarrhoea, stomatitis and ulceration of the mouth, constipation, increased bilirubin, itching, sweating, back pain, myalgia, fever, asthenia, chills. Consult SPC for additional adverse reactions. Legal classification: POM. PA number: PA 1422/003/005. Marketing Authorisation Holder: Fresenius Kabi Oncology Plc., Lion Court, Farnham Road, Bordon, Hampshire, GU350NF United Kingdom. Adverse events should be reported via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Date of Preparation: June 2016.


22 Feature

Sharing in the fight against Cardiovascular Disease ESC President, Professor Fausto Pinto

for ESC Congress 2016 and many more followed the congress from afar. We have had coverage from all over the world. Hot Lines are always the main focus of media attention and are reported all over the world. The ESC Congress is a great source of news for medical, financial and lay media.” At the ESC General Assembly held during the Congress, the ESC Presidency was transferred from Professor Fausto Pinto to Professor Jeroen Bax of the Netherlands.

A record 33,000 dedicated healthcare professionals gathered in Rome for ESC Congress 2016, sharing the latest medical advances in the fight against cardiovascular disease (CVD). CVD is the leading cause of death around the world. It claims the lives of more than 17 million people a year. It is the biggest single cause of death in Ireland every year. Approximately 10,000 people die each year from cardiovascular disease - including coronary heart disease (CHD), stroke and other circulatory diseases. CVD is the most common cause of death in Ireland, accounting for 32% of all deaths. The largest number of these deaths relate to CHD - mainly heart attack - at 5,000 ESC President, Professor Fausto Pinto, brought the cardiovascular summit to a close with a call to action. "Governments, public health systems, clinics, hospitals, universities, we must all recognise the urgency of this public health crisis", he said. "And a crisis is exactly what it is, and how it should be seen.” ESC Congress 2016 featured 26 clinical Hot Line presentations, 21 Clinical Trial Updates, 4 new ESC Clinical Practice Guidelines and 4594 abstracts. “This has been one of the

October 2016 • HPN

most comprehensive scientific programmes yet,” said Professor Geneviève Derumeaux, Chair of the Congress Programme Committee. "This reflects the excellent scientific content submitted to our congress. Cardiologists and other health professionals continue to see ESC Congress as the place to be to keep up to date with the latest developments in cardiology and to meet experts from different fields of research from all over the world.” “If I had to highlight one study, I would quote the DANISH trial” said Professor Steen Dalby Kristensen, Chair of the ESC Media Committee. “This is a very important randomised study showing that not all patients with severe heart failure and normal coronary arteries benefit from implantation of a cardiac defibrillator.” Some other notable studies presented at ESC Congress 2016 include: • REVERSE II: a multi-national validation of a clinical decision rule to identify low risk, unprovoked venous thromboembolism patients who can discontinue anticoagulants. • CONSERVE: direct or selective catheterisation guided by coronary computed tomography

(CT) the preferred choice in patients with stable suspected coronary artery disease. • PACIFIC: the first head-tohead comparison of coronary CT angiography, myocardial perfusion SPECT, PET, and hybrid imaging for diagnosis of ischaemic heart disease. • SAVE: the latest presented prevention strategies in sleep apnoea and resistant hypertension. Professor Joep Perk from Sweden, highlighted studies presented in Hot Lines press conferences. “The report from the US, comparing the effect of long-term exposure to lower LDL-C, lower SBP, or both on the risk of cardiovascular disease impacting on CVD risk below was remarkable. It showed clearly which gains there are still to be obtained in providing effective secondary prevention: the risk for yet another myocardial infarction can be lowered with up to 90%. Furthermore, apheresis as a novel treatment for refractory angina in persons with raised lipoprotein(a) may open a new treatment option for this group of angina patients.” “The wealth of new information in the scientific programme was reflected in the very dense press programme this year,” added Professor Steen Dalby Kristensen. “Over 600 journalists registered

With Professor Bax beginning his term of office, it was formally announced that the next ESC President-Elect would be Professor Barbara Casadei from the United Kingdom. Professor Casadei has been involved with the European Society of Cardiology for several years, most recently holding the position of Vice President for Scientific Affairs. The closing of ESC Congress 2016 was marked by an historic visit by His Holiness Pope Francis to recognise the significant efforts of the ESC and medical professionals worldwide to advance prevention, diagnosis and treatment of heart disease. Some of the most popular news stories coming out of ESC Congress (apart from Hot Lines) this year were (See below for further details): • Mediterranean Diet - The Mediterranean diet is associated with a reduced risk of death in patients with a history of cardiovascular disease. • Alcohol related hospitalisation is associated with a doubled risk of ischaemic stroke risk in patients with non-valvular atrial fibrillation. • Heart failure in the elderly is set to triple by 2060 - The study assessed the prevalence of heart failure in the elderly population and sought to predict the number of elderly people likely to have heart failure in the future.


NEW aspirin • atorvastatin • ramipril

The 1st polypill licensed for secondary prevention of cardiovascular events in Ireland Trinomia 100 mg/20 mg/10 mg, 100 mg/20 mg/5 mg, 100 mg/20 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Hard capsules containing: two 50 mg acetylsalicylic film-coated tablets, two 10 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic filmcoated tablet, two 10 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 10 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet. Uses: Secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses. Dosage: Oral administration. 1 capsule per day, preferably after a meal. Swallow with liquid. Do not chew or crush. Avoid grapefruit juice. Patients currently controlled with equivalent therapeutic doses of acetylsalicylic acid, atorvastatin and ramipril can be directly switched. Treatment initiation should take place under medical supervision. Cardiovascular prevention, target maintenance dose of Ramipril is 10 mg once daily. Daily dose in renal impairment based on creatinine clearance - ≥ 60 ml/min, maximum daily dose is 10 mg ramipril; 30-60 ml/min, maximum daily dose is 5 mg ramipril. Contraindicated in hemodialysis and/or with severe renal impairment (creatinine clearance <30 ml/min). Administer with caution with hepatic impairment. Perform liver function tests before initiation of treatment and periodically thereafter. Maximum daily dose of is 2.5 mg ramipril and initiate treatment under close medical supervision. Contraindicated in severe or active hepatic impairment. Start treatment in very old and frail patients with caution. Contraindications: Hypersensitivity to any component, to other salicylates, to NSAIDs, to any other ACE inhibitors, tartrazine, soya or peanut. History of previous asthma attacks or other allergic reactions to salicylic acid or other NSAIDs. Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, other kinds of bleeding. Haemophilia and other bleeding disorders. Severe kidney and liver impairment. Hemodialysis. Severe heart failure. Concomitant treatment with methotrexate at a dosage of 15 mg or more per week. Concomitant use with aliskiren-containing products with diabetes mellitus or renal impairment. Nasal polyps associated with ashma induced or exacerbated by acetylsalicylic acid. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy, lactation and in women of childbearing potential not using appropriate contraceptive measures. Concomitant treatment with tipranavir, ritonavir, ciclosporin. History of angioedema. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. Hypotensive or haemodynamically unstable states. Children and adolescents below 18 years of age. Warnings and Precautions: Only for use as a substitution therapy in patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses. Special populations requiring particularly careful medical supervision: Hypersensitivity to other analgesics/ antiinflammatory/antipyretic/antirheumatics or other allergens. Other known allergies, bronchial asthma, hay fever, swollen nasal mucous membranes and other chronic respiratory diseases. History of gastric or enteric ulcers, or of gastrointestinal bleeding. Reduced liver and/or renal function. Particular risk of hypotension: strongly activated renin-angiotensin-aldosterone system, transient or persistent heart failure post MI, risk of cardiac or cerebral ischemia, in case of acute hypotension medical supervision including blood pressure monitoring is necessary. Deterioration of cardiovascular circulation. Glucose 6 phosphate dehydrogenase deficiency. Risk of elevated levels of uric acid. Consumption of substantial quantities of alcohol and/or have a history of liver disease. Diagnosed pregnancy, stop treatment immediately, and, if appropriate, start alternative therapy. ACE inhibitors cause higher rate of angioedema in black patients than in non-black patients. The blood pressure lowering effect of ACE inhibitors is somewhat less in black patients than nonblack patients. Monitoring during treatment is required for: Concomitant treatment with NSAIDs, corticosteroids, SSRIs, antiplatelet drugs, anticoagulants. Signs or symptoms suggestive of liver injury. Stop treatment temporarily prior to elective major surgery and when any major medical or surgical condition occurs. Particularly careful monitoring is required in patients with renal impairment, risk of impairment of renal function, particularly with congestive heart failure or after a renal transplant. Risk of development of

hyperkalaemia – regular monitoring of serum potassium recommended. Specific side-effects: Perform liver function tests periodically if hepatic effects occur. May affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, ask patients to promptly report skeletal muscle effects (muscle pains, cramps or weakness) especially if accompanied by malasie or fever and measure CK levels, stop treatment if significantly elevated or if severe muscular symptoms occur. Do not co-administer with systemic fusidic acid or within 7 days of stopping fusidic acid. Where use of systemic fusidic acid considered essential, discontinue statin treatment during fusidic acid treatment. Reports of rhabdomyolysis in patients receiving fusidic acid and statins in combination. Where prolonged systemic fusidic acid needed, consider need for co-administration of Trinomia and fusidic acid on case by case basis with close medical supervision. Discontinue statin treatment if interstitial lung disease occurs. Monitor patients at risk of diabetes mellitus. Discontinue treatment if angioedema occurs and initiate emergency treatment promptly. Concomitant use of ACE-inhibitors and angiotensin II receptor blockers or aliskiren is not recommended and should not be used in patients with diabetic nephropathy. Anaphylactic reactions during desensitization, consider temporary discontinuation of Trinomia during desensitization. Monitor white blood cells for neutropenia/agranulocytosis and more regularly in the initial phase of treatment, impaired renal function, concomitant collagen disease and other mediciens that can change the blood picture. Cough. Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Acetylsalicylic acid: other platelet aggregation inhibitors, other NSAIDs,and antirheumatics, systemic glucocorticoids, diuretics, alcohol, SSRIs, uricosuric agents, anticoagulant and thrombolytic therapy, digoxin, antidiabetic agents including insulin, methotrexate, valproic acid, , antacids, ACE inhibitors, ciclosporin, vancomycin, interferon ∝, lithium, barbiturates, zidovudine, phenytoin, laboratory tests. Atorvastatin: CYP3A4 inhibitors, CYP3A4 inducers, transport protein inhibitors, gemfibrozil/fibric acid derivatives, ezetimibe, colestipol, fusidic acid, colchicine, digoxin, oral contraceptives, warfarin. Ramipril: potassium salts, heparin, potassiumretaining diuretics and other plasma potassium increasing active substances, antihypertensive agents and other substances that may decrease blood pressure, vasopressor sympathomimetics and other substances, allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count, lithium salts, antidiabetic agents including insulin. Monitor as appropriate. Pregnancy and Lactation: Contraindicated in pregnancy. Not recommended during lactation. Women of child-bearing potential should use effective contraception during treatment. Side Effects: Ramipril: Common (≥ 1/100, <1/10): dyspepsia, nausea, diarrhoea, vomiting, digestive disturbances, abdominal discomfort, gastrointestinal inflammation, non-productive tickling cough, bronchitis, sinusitis, dyspnoea, headache, dizziness, rash in particular maculo-papular, blood potassium increased, myalgia, muscle spasms, chest pain, fatigue, hypotension, orthostatic blood pressure decreased, syncope. Atorvastatin: Common: dyspepsia, nausea, diarrhoea, constipation, flatulence, pharyngolaryngeal pain, epistaxis, nasopharyngitis, headache, allergic reactions, hyperglycaemia, myalgia, muscle spasms, pain in extremity, joint swelling, back pain, arthralgia, liver function test abnormal, blood creatine kinase increased. ASA: Very Common (≥ 1/10): Gastrointestinal complaints such as heartburn, nausea, vomiting, stomach ache and diarrhea, minor blood loss from the gastrointestinal tract (micro-bleeding). Common: Paroxysmal bronchospasm, serious dyspnoea, rhinitis, nasal congestion. For less frequent side effects see SmPC. Pack Sizes: Blister containing 28 film-coated tablets. Legal Category: POM. Product Authorisation Numbers: PA 1744/002/001-003. Product Authorisation Holder: Ferrer Internacional, S.A., Gran Vía Carlos III, 94, 08028 Barcelona, Spain. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC. Date of Preparation: September 2016 Date of item: September 2016. IR-Tri-012-2016


24 Feature ALCOHOL RELATED HOSPITALISATION IS ASSOCIATED WITH A DOUBLED RISK OF ISCHAEMIC STROKE RISK IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION Alcohol related hospitalisation is associated with a doubled risk of ischaemic stroke risk in patients with non-valvular atrial fibrillation, according to a study presented at ESC Congress 2016 by Dr Faris Al-Khalili, Cardiologist, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.(1) The observational study was conducted in more than 25 000 non-valvular atrial fibrillation patients at low risk of stroke.(2) “Atrial fibrillation (AF) is the most common heart rhythm disturbance and is associated with a fivefold increased risk of ischaemic stroke,” said Dr Al-Khalili. “AF is also associated with increased mortality, reduced quality of life and a higher risk of heart failure.” Treatment with oral anticoagulants reduces the risk of stroke and is recommended according to the number of stroke risk factors. Risk is estimated using the CHA2DS2VASc score which gives points for clinical risk factors.(3) Patients with non-valvular AF under the age of 65 and a score of 0 in men or 1 in women are considered to be at low risk for ischaemic stroke, and oral anticoagulation therapy is not indicated. Dr Al-Khalili said: “Even if the risk for stroke is low, it is not negligible, and a number of such ‘low risk’ patients do present with ischaemic stroke in clinical practice and in patient registers.” The objective of this study was to assess the incidence and predictors of ischaemic stroke among low risk patients with non-valvular AF. This retrospective study included 25 252 low risk non-valvular AF patients (age 18–64) out of a total of 345 123 AF patients identified from the Swedish nationwide patient register for the period 1 January 2006 to 31 December 2012. The median age was 55 years and 72% were men. The patient register holds information about all hospitalisations and visits to hospital-affiliated open clinics in Sweden. Socioeconomic variables were obtained from a database for health insurance and labour market studies. Information about current medication was obtained from the National Drug Register,

October 2016 • HPN

which has information about all dispensed prescription in Sweden and is 100% complete. During a median follow-up of five years, ischaemic stroke occurred at an annual rate of 3.4 per 1000 patient-years. The overall mortality was 7.5 per 1000 patient-years in patients without ischaemic stroke, and 29.6 per 1000 patient-years in patients who had suffered an ischaemic stroke during follow-up. In the multivariable analysis, the only variables that remained significantly associated with an increased risk of ischaemic stroke were age (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.05–1.08, p <0.001 per incremental year) and alcohol related hospitalisation (HR 2.01, 95% CI 1.45 – 2.79, p <0.001). Use of oral anticoagulants was associated with a lower risk of ischaemic stroke (HR 0.78, 95% CI 0.63-0.97, p= 0.027). Dr Al-Khalili said: “Even through these patients are classified as low risk, the incidence of ischaemic stroke in our study population is neither negligible nor ignorable and it carries a relatively high mortality.” “Previous studies have shown a causal and dose-response relation between alcohol and AF,” he added. “Our study found that alcohol is an independent risk factor for stroke in patients with AF. Alcohol might induce AF, leading to embolic stroke, or there could be a specific alcohol effect which causes systemic or cerebral thromboembolism. Using alcohol related hospitalisation as a proxy for alcohol abuse likely underestimates the extent of the problem, and does not allow grading of the amount of alcohol consumed.” Dr Al-Khalili concluded: “Doctors should ask their AF patients about alcohol use and advise patients to cut down if they are drinking more than is recommended. The beneficial link between oral anticoagulant use and ischaemic

stroke in this low risk population without a recognised indication for these drugs needs further investigation, including the benefit to harm (bleeding) ratio.” References (1) Dr Faris Al-Khalili will present the abstract ‘Alcohol abuse is associated with increased risk of ischemic stroke in low risk patients with non-valvular atrial fibrillation’ during: • The press conference “Stroke and Arrhythmia: Life or Death” on 27 August at 15:00 to 16:00. • The session Antithrombotic therapy in atrial fibrillation I on 29 August at 15:35 to 16:25 at the Moderated poster station, Poster Area. (2) Atrial fibrillation (AF) can be “valvular or “non-valvular”. Valvular AF refers to AF related to rheumatic valvular disease (predominantly mitral stenosis) or prosthetic heart valves. (3) Risk of ischaemic stroke in patients with non-valvular atrial fibrillation (AF) is estimated with the CHA2DS2-VASc score system which gives points for clinical risk factors: one point each for congestive heart failure, hypertension, age 65–74 years, diabetes mellitus, vascular disease, and female sex, and two points each for age >75 years, and previous stroke/transient ischaemic attack. Treatment with oral anticoagulants is recommended in male AF patients with one or more points and female AF patients with two or more points. HEART FAILURE IN THE ELDERLY SET TO TRIPLE BY 2060 Heart failure in the elderly is set to triple by 2060, according to new data from the Age, Gene/ Environment Susceptibility (AGES) - Reykjavík study presented at ESC Congress 2016.(1)

“Heart failure is a common condition worldwide and increases with age,” said lead author Professor Ragnar Danielsen, a Cardiologist at Landspitali University Hospital in Reykjavik, Iceland. “Various disorders can cause heart failure, such as coronary heart disease, hypertension, obesity and diabetes. As these are more prevalent with age the consequence is an increased population of elderly who may develop heart failure.” The AGES-Reykjavík study began in 2002 as a collaboration between the National Institute on Aging in the United States and the Icelandic Heart Association. The current analysis included data from 5706 randomly selected elderly participants who represented the total population of Iceland. The investigators used official government data from Statistics Iceland on the current size, sex and age distribution of the national population and its predictions up to 2060. Combining these data, the study assessed the prevalence of heart failure in the elderly population and sought to predict the number of elderly people likely to have heart failure in the future. Participants’ age ranged from 66 to 98 years, the mean age being 77 years, and 58% were men. The prevalence of heart failure was 3.7% in the sexes combined, but it was higher in men, 4.8%, compared to 2.8% in women. The prevalence of heart failure increased with age, from 1.9% in those 69 years of age or younger, to 6% in those 80 years of age and older (see table 1 below). The number of elderly people according to age groups was estimated for the coming decades in both men and women, until 2060 (Figure 1). The largest increases will be in the age groups 70 to 79 years and 80 years and older and predominantly in women.

Table 1: The prevalence (%) of heart failure according to age groups and gender Age groups

Both sexes

≤ 69 years

1.9

Men

Women

3.7

0.9

70-79 years 2.5 3.5 1.3 ≥ 80 years

6.0

7.4

5.0


25 Figure 1

Smoking • Restrict advertising, marketing and sale of smokeless tobacco. • Ban smoking in school, pre-school and child care to protect from passive smoking. • Advise parents to be tobacco-free when children are present and never smoke in cars or at home. • Give electronic cigarettes the same marketing restrictions as cigarettes.

Professor Danielsen said, “This study predicts that heart failure in the elderly will more than double by 2040 and triple by 2060. In the coming decades the majority of heart failure patients will be elderly individuals and this will have major health-economical consequences.” He concluded: “The findings are a wake-up call for policy makers and healthcare providers that more needs to be done to prevent heart failure. This includes giving prompt treatment for heart attacks and encouraging adherence to preventative therapies and lifestyle changes afterwards.” References (1) Professor Ragnar Danielsen will present the abstract “Heart failure in the elderly and predictions for the future: The AGES-Reykjavik Study” during: • The press conf)erence “Heart failure, challenges and solutions” on 28 August at 13:00 to 14:00. • Poster session 6: Heart failure/ Left ventricular function on 30 August at 08:30 to 12:30 in the Poster Area. NEW JOINT CARDIOVASCULAR PREVENTION GUIDELINES New Joint European Cardiovascular Prevention Guidelines emphasising population approaches for the first time have been published in European Heart Journal,1 the European Journal of Preventive Cardiology and other specialty journals. The document gives the latest advice on prevention of cardiovascular disease (CVD) in individuals and populations and

was launched at Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure in Florence, Italy. Key messages will be presented at ESC Congress. “The last 30 years have witnessed a decrease in deaths from CVD, mainly due to improved treatment of heart disease, and falls in cholesterol, blood pressure and smoking,” said Professor Massimo F. Piepoli, Chairperson of the guidelines Task Force. “This trend is partly offset by rising obesity and type 2 diabetes, and poor adherence to lifestyle changes.” Irish Co-authors were Professor Ian Graham, Chair of Cardiology at Trinity College Dublin and Dr Marie Therese Clooney from St Vincent’s Hospital. The document was written by the sixth joint Task Force of the European Society of Cardiology and nine other societies. It argues that CVD mortality rates could be halved by modest risk factor reduction. New scientific evidence has led to adapted target levels for important risk factors, such as blood pressure and lipids. Special attention has been dedicated to younger adults and to the elderly.

• Legislate to restrict marketing foods high in fat, sugar and salt to children. • Tax foods rich in sugar and saturated fat, and alcoholic drinks. • Make water and healthy food available in schools and workplaces. • Regulate location and density of fast food outlets. Physical activity • Consider physical activity when planning new landscaping, buildings or towns. • Post signs to encourage use of stairs. • Increase fuel taxes. • Provide tax incentives to buy exercise equipment or gym membership. • Give financial incentives to lose weight and increase fitness.

The detrimental impact of air pollution on heart health is highlighted, and the authors say the media can inform the public about air quality (for example by using apps) and provide smog alerts. Air quality can be improved by reducing taxes on electrical and hybrid cars. New houses and schools should be built away from highways and polluting industries. Professor Piepoli said, “A healthy environment is essential for preventing CVD. Lawmakers need to take more responsibility for their nation’s wellbeing by taxing unhealthy choices and incentivising healthy ones.” Novel recommendations are given for patients with rheumatoid arthritis, erectile dysfunction, and patients receiving treatment for cancer. Women with a history of pre-eclampsia, premature birth, polycystic ovary syndrome or gestational diabetes should be screened for diabetes and hypertension. CVD risk varies considerably between immigrant groups and ethnicity should be considered in CVD risk assessment. Professor Arno W. Hoes, Task Force Co-chairperson, added, “The recommendations cover the entire spectrum of CVD prevention in individuals and populations. We all have a role to play to stop heart disease.”

Reducing population risk by 1% would prevent 25 000 CVD cases and save ¤40 million per year in a single European country. Stronger laws and policies on food, physical activity and smoking are needed, such as: Food • Legislate food composition to reduce calories, salt, saturated fat, sugar, and limit portion sizes • Eliminate industrially produced trans fats.

HPN • October 2016


26 News

New Model of Care for Neurology A new Model of Care for neurological services in Ireland has been launched by Tony O’Brien, Director General, HSE in the Mater Misericordiae University Hospital. The model of care, written by Professor Tim Lynch, maps out the future set up of acute and chronic neurological services in Ireland. The model outlines that such services will be delivered in an efficient, equitable and cost effective manner by supported, skilled, professionals working in a multidisciplinary manner using a person-centred approach to care. Over 700,000 people in Ireland have a neurological illness which accounts for one in five acute

medical admissions, with one in eight patient attendances to a general practitioner. Many of these brain, spinal, nerve and muscle disorders are increasingly treatable but access to diagnosis and treatment in Ireland presents a challenge. The HSE, working in close partnership with the Royal College of Physicians of Ireland, have launched the new Model of Care for Neurological Services in Ireland which was developed by the many professional groups working with patient support groups. Mr O’Brien was joined by Dr Aine Carroll, HSE National Director for Clinical Programs, a number of patients, past and present, who

have suffered from neurological conditions and Prof Tim Lynch, Consultant Neurologist and clinical lead in the National Clinical Programme for Neurology, at the publication of a new “Model of Care for the National Clinical Programme of Neurology”. The Model of Care for Neurology provides a framework for neurology services using international best practice and describes care provision using an integrated service approach. It covers the full spectrum of care provided in hospitals (in-patient & out-patient) and makes specific recommendations to the type of care considered best practice in the management of patients with

long term neurological conditions in the community. Professor Tim Lynch, National Clinical Lead for Neurology said, “The brain is the most important organ of the body and we need to encourage understanding and approaches to brain health in Ireland. This model of care is intended to ensure we provide excellent care for patients with neurological illness and also to stimulate teaching of and research into clinical neurology. There is no medicine like hope. We hope we will give hope to people with neurological illness with the publication and implementation of this model of care.”

Cyberknife Programme event held at Hermitage The Hermitage Medical Clinic held it’s CyberKnife Symposium at the end of September. The event was attended by Consultants and GPs. Mr Danny Rawluk, Consultant Neurosurgeon and Clinical Director CyberKnife Programme chaired the session. Speakers included Dr Patrick Maguire on CyberHeart. Dr Clare Faul spoke on Current Concept in Spinal Radiosurgery. Guest speaker, Dr Anand Mahadevan, Consultant Radiation Oncologist from Boston spoke on Stereotactic Body Radiotherapy for Liver and Pancreatic Cancer. The CyberKnife System, a noninvasive alternative to surgery for the treatment of cancerous and non-cancerous tumours anywhere in the body. It was introduced to Ireland for the first time at the Hermitage Medical Clinic.

Dr Anand Mahadevan, Consultant Radiation Oncologist, Boston and Dr Osama Salib, Radiation Oncologist, Hemitage Medical Clinic

Dr Tora Leung, Consultant Cardiologist and Dr Ian Fraser, Consultant Radiation Oncologist, Hermitage Medical Clinic

Mr Danny Rawluk, Consultant Neurosurgeon and Clinical Director Cyberknife Programme

Dr Pedro Franco, Naas General Hospital and Dr Patrick Maguire, President, CyberHeart

The CyberKnife treatment works by sending multiple beams of high dose radiation from a wide variety of angles using a robotic arm. X-ray cameras monitor the patient’s breathing and re-position the radiotherapy beam in order to minimise damage to healthy tissue. This accuracy enables tumours to be treated that are in difficult or dangerous to treat positions such as near the spinal cord, prostate, lung, brain, liver, pancreas and kidney. Other speakers from Hermitage Medical Clinic included Dr Osama Salib and Dr Ian Fraser, Radiation Oncologists. October 2016 • HPN


CPD 25: Gram Negative Continuing Professional Development

CPD

27

C. O’Connora,b, M. Cormicanc,d, T.W. Boo c,d, E. McGrathd, B. Slevine, A. O’Gormane, M.Commanee, S. Mahonyb, E. O’Donovane, J. Powella, R. Monahana, C. Finnegana, M.G. Kiernanb, J.C. Coffeyb, L. Powera, N.H. O’Connella,b, C.P. Dunneb,* Department of Clinical Microbiology, University Hospital Limerick, Limerick, Ireland Centre for Interventions in Infection, Inflammation & Immunity (4i) and Graduate Entry Medical School, University of Limerick, Limerick, Ireland c School of Medicine National University of Ireland Galway, Galway, Ireland d Carbapenemase-Producing Enterobacteriaceae (CPE) Reference Laboratory, Department of Medical Microbiology, University Hospital Galway, Galway, Ireland e Department of Infection Prevention and Control, University Hospital Limerick, Limerick, Ireland a

b

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

3. PLAN - If I have identified a knowledge gap - will this article satisfy those needs or will more reading be required?

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?

60 Second Summary Enterobacteriaceae are Gram-negative colonizers of the human gut. Carbapenemase-producing Enterobacteriaceae (CPE) are resistant to most classes of antimicrobials. New Delhi metallo-βlactamase-1 (NDM-1) is among the most recently discovered carbapenemase enzymes. In this report, we describe what we believe to be the first outbreak of NDM-1-producing Enterobacteriaceae in Ireland, which occurred in 2014. Patients in our hospital group were screened on admission for CPE if: admitted to the intensive care unit (ICU) or high dependency unit (HDU) at UHL; transferred from another hospital in Ireland; have had an acute admission in the past 12 months to any hospital within our hospital group (except for paediatric, maternity, or orthopaedic); or hospitalized abroad. Haemodialysis patients are screened every three months. Patients in ICU and HDU are screened weekly until discharge. The isolation of NDM-1-producing K. pneumoniae triggered initiation of the hospital’s outbreak management protocol. Rectal swabs or stool samples were obtained from all contacts of the index case. Information leaflets were distributed to all patients and family as appropriate. A further initiative was introduced involving, on a daily basis, a joint pharmacist/clinical microbiologist handover of all in-house carbapenem prescriptions, and subsequent discussion by the either the microbiology consultant or registrar with clinical teams regarding alternative agents where appropriate. During the outbreak, between June and September 2014, nine patients with NDM-1producing K. pneumoniae and one patient with both NDM-1-producing Escherichia coli and KPC producing Enterobacter cloacae were detected. The isolates were detected in samples from UHL and from two affiliated regional hospitals, located 10 and 40 km away. Prior to this outbreak, no cases of NDM-producing Enterobacteriaceae had been identified in our laboratory. The source of the index patient’s NDM-1-producer acquisition remains uncertain although acquisition during the hospital admission of June 2014 is considered likely.

5. WHAT NEXT - At this time you may like to record your learning for future use or

assessment. Follow the 4 previous steps, log and record your findings. Published by HPN, sponsored by MSD. Copies can be downloaded from www.irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author. MSD has no editorial oversight of the CPD programmes included in these modules.

An Irish outbreak of New Delhi metallo-b-lactamase (NDM)-1 carbapenemase-producing Enterobacteriaceae: increasing but unrecognised prevalence Introduction Enterobacteriaceae are Gram-negative colonizers of the human gut. Carbapenemaseproducing Enterobacteriaceae (CPE) are resistant to most classes of antimicrobials.1 New Delhi metallo-b-lactamase-1 (NDM-1) is among the most recently discovered carbapenemase enzymes. The responsible blaNDM-1 gene is thought to have originated in the environment from plant pathogens and is plasmid-borne.2 NDM-1 confers broad-spectrum b-lactam resistance mediated by hydrolysis of all b-lactam antimicrobials, with the exception of monobactams, such as aztreonam.3 Many NDM-1-producing bacteria remain susceptible only to colistin, fosfomycin, and tigecycline.4,5 Since first reported as implicated in human disease, NDM-1-producing bacteria have been recovered from numerous infection sites including device-associated infections, intraabdominal, urinary tract, bloodstream, and surgical wounds.6,7 Publications have described most variants of the enzyme as having originated in Asia.8 Acquisition of NDM-1-producers has been reported as associated with travel to known reservoir areas, notably the Indian subcontinent (Pakistan, India, Sri Lanka) and the Balkan countries, where prevalence of community carriage is estimated to be 5-15%.9-12 Global dissemination is facilitated by intercontinental travel, including healthcare tourism, and migration.13-15 International

spread has been rapid.16 The NDM isolates identified in Ireland prior to this outbreak were isolated or paired cases from several hospitals countrywide and generally with an identifiable link with travel. Dissemination of the blaNDM-1 gene, like other similar resistance mediators, is facilitated by inadequate infection prevention and control practice in healthcare settings, uncontrolled or poorly controlled antimicrobial use, inadequate practices related to food preparation and water treatment, and poor general sanitation.13,17-19 The largest reported NDM outbreak to date in a non-endemic country was reported from Poland in 2015, where 374 cases of infection or colonization, with a variety of NDM producing Enterobacteriaceae, were identified from 40 hospitals over a two-year period.20 In this report, we describe what we believe to be the first outbreak of NDM-1-producing Enterobacteriaceae in Ireland, which occurred in 2014. Methods Setting The Department of Clinical Microbiology at University Hospital Limerick (UHL) provides a centralized microbiology service for six acute hospital sites (800 beds; population circa 380,000 people). As an aid to contextualizing this outbreak, it is notable that 48 K. pneumoniae carbapenemase (KPC) and one imipenem-hydrolysing b-lactamase (IMI)-

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.


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producing isolates were detected at UHL between February 2009 and May 2015, as previously published.21

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ME140289 June 2014

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ME140290 June 2014

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ME140282 June 2014

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A CPE screening policy was in ME140368 Aug 2014 Rectal place before the outbreak began. ME140369 Aug 2014 Rectal Patients in our hospital group ME140372 Aug 2014 Rectal were screened on admission for CPE if: admitted to the ME140396 Aug 2014 Rectal intensive care unit (ICU) or high ME140428 Aug 2014 Rectal dependency unit (HDU) at ME150339 Aug 2015 Urine UHL; transferred from another ME150380 Sept 2015 Rectal hospital in Ireland; have had an ME140453 Sept 2014 Urine acute admission in the past 12 ME150492 Oct 2015 Rectal months to any hospital within our hospital group (except Figure 1. Pulsed-field gel electrophoresis of 12 Klebsiella pneumoniae isolates. ME 140282 is the index case. for paediatric, maternity, or orthopaedic); or hospitalized Given the identification of NDM-1 at three different associabroad. Haemodialysis patients IV tigecycline 50 mg every 12 h was initiated and the site was ated hospitals, a decision was made to perform contact tracing surgically. The patient died two months following are screened every three months. debrided employed for bathing of patients. in affected areas, which involved acid; meropenem þ boronic and screening of all contacts at each site. As a result of that admission secondary to refractory soft tissue sepsis. Patients in ICU and HDU are Dedicated equipment was twice weekly observational acid; meropenem þ cloxacillin) exercise, during the outbreak, 2204 CPE screens, including screened weekly until discharge. prioritized for NDM-positive ward level. Enhanced were used to phenotypically contact tracing and audits routine at CPE screening, were processed in inpatients, both infected cleaning, twice daily, of all distinguish CPE isolates. our laboratory, which in addition to detecting the NDM-1 isoEvolution of the outbreak Study definitions and colonized, but lates, was not areas and Isolates were referred to the also identifiedimplicated 13 new KPCsclinical and one OXA-48. Cases were defined as patients available patient equipment was instigated National CarbapenemaseThe patient demographics are summarized in Tablefor I; all all NDM contacts. with a NDM-1 positive culture A semiautomated electronic were permanent Irish residents. During the outbreak, our in parallel with increased auditing Producing Enterobacteriaceae Carbapenem consumption from any site during their routine screening programme was extended to include weekly system, ICNet data surveillance of cleaning practice. The index (CPE) Reference Laboratory hospitalization. Contacts were testing of rectal swabs or specimens from patients with (Baxter, Gloucester, UK), cases’ room in the ICU and Service (CPERLS) at stool University Onlywas the index case had been prescribed meropenem during designated as room or ward epidemiological and environmental confirmed CPE- the records to collate of admission; all ward areas,had where positive Hospital Galway, Ireland for links toused the current the patient received five days of positive CPE screening was performed for a period mates. Microbiological and the outbreak meetings and meropenem before the isolation of an NDM-positive NDM-1 patients had been culture. CPE patients. confirmation by molecular of four weeks after no new cases of CPEpatients colonization or 24 All patients molecular detection of NDM-1 involved. admitted, underwent routine methods. Genetic relationship infection had been detected. identified as CPE positive as cleaningpost followed by hydrogen of NDM-1 isolates was NDM-1 or isolates identified outbreak In June 2014, two contacts of the index case prior to her ICU Since 2011, CPE surveillance CPE contact were flagged on the peroxide vapour decontamination determined by pulsed-field gel admission were identified (patients B, D). Both had been on the at UHL had been performed ICNet and their In medical week 31, 2015post (i.e. discharge. 10 months after the clean 2014 outbreak A deep electrophoresis (PFGE). medical ward with the index case during her 24 h system admission on stool samples or rectal ended), NDM-1-producing pneumoniaedepartment was identified in an charts were assigned a CPE alert of theK.emergency before transfer to ICU. Patient B was screened, identified as swabs using KPC-producer mid-stream urine sample from an 81-year-old female sticker,D placed front cover. Details of NDM-1-positive (ED) including the waiting roomresiding NDM-1-producer positive and was isolated. Patient was dis-on the selective chromogenic agar in a private long-term care facility (LTCF). This patient was a patients and resuscitation areas was charged prior to CPE screening. She re-presented for admission During the 13 weeks of thisof the index case during the outbreak but CPE was not (CHROMagarKPC, Paris, contact A retrospective reviewto a six-bedded area on the in July 2014 and waschart re-admitted performed as seven patients outbreak, an additional 13 KPCs France). Matrixassisted laser detected at the time. PFGE demonstrated similarity to the same medical ward to and which she had been admitted in June assessing clinical involved in the outbreak had been 2014 isolates. In week 32, 2015, NDM-1-producing and one oxacillin-hydrolysing desorption/ionization time-of2014. CPE screening confirmed that she was NDM-1-producer epidemiologic characteristics theaED. High-touch K. pneumoniae identifiedvia from rectal swab of a 71carbapenamase were wasadmitted flight mass spectrometry (Bruker positive and she was isolated immediately. Patients E, F, and (OXA-48) was completed for all patients surfaces such as door handles, year-old public LTCF patient who was known to have been identified. This was the first OXA Diagnostics) identification was H were ward contacts of the index involved, including: dates of case, and patients G and I lockers, and chairs freundii. previouslybedside with KPC-producing Citrobacter performed on all colonies, isolated at UHL. At colonized a practical were identified from routine admission rectal CPE screens admission, transfers, and hospital and bed rails were emphasized This isolate did not demonstrate similarity to previous isolates. as previously described.22 with the performed during the outbreak period. level, Both staff had were been familiar discharges; locations within by the hospital K. hygiene nurse was isoweek 42, 2015, NDM-1-producing pneumoniae neither had had Antimicrobial susceptibility testing admitted to UHL in the previous 12 months;term ‘KPC’, but theInintroduction the hospital; procedures and lated by rectal swab manager from an admission CPE screen of a patient for cleaning to reduce contact with the index case. was performed using broth of the terms ‘NDM’ and ‘OXA’ repatriated from Bosnia. She had not beenAnadmitted to UHL operative notes;NDM-1-producer use of invasivepositive patients were cross-transmission. ultraviolet Two additional microdilution (ARIS Sensititre created confusion, previously and the and had never had any specimens processed in the devices; biochemical and torch was used to assess the identified during the outbreak period, but that had no apparent system, Thermo Fisher Scientific, concept of three different types UHL microbiology laboratory. In weekperformed 48, 2015, NDM-1haematological blood test results; quality of cleaning epidemiologic link with the outbreak cases. Patient C was Inc., MA, USA). of CPE circulating simultaneously producing E. coli was detected in a 60-year-old patient who antimicrobials received identified as CPE positive fromand a screening rectal swab that was and face-toface feedback generated alarm among clinical had been recently hospitalized in India (Figure 2). Again, these at a regional 10 km from UHL. This CPE documentation of a hospital travel history. regarding cleaning deficits was Elevated carbapenem minimum performed staff. Members of the infection isolates did not demonstrate similarity to the outbreak strain. been admitted supplied to cleaning operatives. inhibitory concentrations (MICs) screen was performed because the patient had prevention and control team to UHL in the previous 12 months but his last admission to UHL Infection control interventions Environmental sampling was not for meropenem and ertapenem education hadThe been almostoffive months before theprovided outbreakadditional was Discussion isolation NDM-1-producing performed during this outbreak. were confirmed by Etest (AB sessions at ward level to nursing declared. Patient J was identified as CPE positive from a urine K. pneumoniae triggered initiation Biodisk, Solna, Sweden) following sample staff and healthcare assistants. collected at a outbreak regional hospital 40 km away from UHL; The source of the index patient’s NDM-1-producer acquisiof the hospital’s A further initiative was introduced the European Committee on posters were designed this isolate was determined by PFGE (Figure 1)New to beCPE the isolate tion remains uncertain although acquisition during the hospital management protocol. Rectal involving, on a daily basis, a joint Antimicrobial Susceptibility the different CPE of types most distantly related to the other outbreak explaining isolates. admission June 2014 is considered likely. The index case had swabs or stool samples were pharmacist/clinical microbiologist Testing (EUCAST) guidelines; in simple and clear language, obtained from all contacts of the handover of all in-house ertapenem resistance MIC >1 and these were placed in the Please citecase. this article in press as: O’Connor C, et al., An Irish outbreak of New Delhi metallo-b-lactamase (NDM)-1 carbapenemase-producing index Information leaflets carbapenem prescriptions, and g/L, meropenem resistance MIC Enterobacteriaceae: doctors’ residence (communal but unrecognized prevalence, Journal of Hospital Infection (2016), http://dx.doi.org/10.1016/ were distributedincreasing to all patients subsequent discussion by the >8 g/L. Isolates with elevated living space) and on all wards. j.jhin.2016.08.005 and family as appropriate. The either the microbiology consultant carbapenem MICs were further Anecdotal feedback received Public Health England CPE or registrar with clinical teams evaluated using the modified regarding the posters was toolkit was implemented during regarding alternative agents Hodge test (MHT). positive. An electronic link to the the outbreak.23 All infected or where appropriate. location of the CPE guideline Commercially available diagnostic colonized patients were barrieron the hospital intranet was Results nursed using long sleeved kits (Rosco Diagnostica A/S, disseminated on a memo disposable gowns and gloves, During the outbreak, between Taastrip, Denmark) consisting of to all staff. and single rooms were used June and September 2014, nine meropenem discs supplemented when available. Chlorhexidine patients with NDM-1-producing Hand hygiene audits were with b-lactamase inhibitors gluconate wash-cloths were K. pneumoniae and one patient performed with greater frequency (meropenem þ dipicolinic

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.


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with both NDM-1-producing Escherichia coli and KPC producing Enterobacter cloacae were detected. The isolates were detected in samples from UHL and from two affiliated regional hospitals, located 10 and 40 km away. Prior to this outbreak, no cases of NDM-producing Enterobacteriaceae had been identified in our laboratory. None of the patients in this outbreak were known to have previous colonization with extendedspectrum b-lactamase (ESBL) producers based on previous screening. Three of the patients had been screened for CPE before this outbreak, and had been found to be negative on those occasions.

C. O’Connor et al. / Journal of Hospital Infection xxx (2016) 1e7

ME140389 Aug 2014 Rectal ME150567 Nov 2015 Rectal Figure 2. Pulsed-field gel electrophoresis of the two NDM-1 Escherichia coli isolates.

been on haemodialysis for 16 years and switched to peritoneal Influenced by this outbreak, our antimicrobial stewardship dialysis in 2013 (five months prior to NDM-1 detection). In our has been modified. Overall hospital antibiotic consumption not detected the time. forall ICU patients) detected period. BothCPE had been care, haemodialysis patients undergo surveillance rate admitted in defined dailywas doses (DDD) per 100atbed-days used (BDU) CTX-M extended spectrum UHL in the previous 12 PFGE demonstrated screening every three months, but the sameto screening is not demonstrates a reduction in carbapenem similarity consumption. Beb-lactamase (ESBL)-producing months; neither had contact the of 2014 isolates. In week conducted for peritoneal dialysis patients. The index case pa- hadtween 2014 and thetoend 2015, carbapenem consumption pneumoniae NDM-1with theatindex 32, 2015, NDM-1-producing K. DDD/ tientK.was screened forand rectal CPE in December 2013, whichcase.decreased by 21% (2014: 4.43 DDD/100 BDU, 2015: 3.49 K. detected. pneumoniae. The her transition to peritimeproducing CPE was not Following 100 BDU). This compares very favourably with a 4% increase pneumoniae was identified from additional toneal dialysis, no further CPE screening wasTwo performed priorNDM-1-producer from 2013 (4.24 DDD/100 BDU) to 2014, from 2012 patient subsequently developed a rectal swab of a25% 71-increase year-old to her transfer ICU diagnostic on this final admission positive to UHL, atpatients which were (3.39 DDD/100 BDU)public to 2013, a 36% increase identified a skin rash,toand LTCF patient whofrom was2011 (2.50 30 timebiopsies CPE was were likewise undetected. worked in a DDD/100 during the outbreak period, BDU) to 2012. performed on She had never known to have been colonized healthcare norAn lived with any healthcare In conclusion, this outbreak and our other sporadic isolates but workers. that hadShe no apparent the leftsetting forearm. abscess previously with KPC-producing had developed no known travel to skin NDM-1 endemic areas.epidemiologic link with indicate epidemiology of NDM-1 CPE. In Ireland, the the changing at the biopsy Citrobacter freundii. Insite; thisCTX-M outbreak, international travel was not a recognized as elsewhere (e.g. Canada), a history of travel to a known outbreak cases. Patient C was ESBL-producing factor, implying that there may be a hospital and/or community endemicfrom areaais of decreasing value in identifying persons at identified as CPE positive K. pneumoniae and NDMThis isolate did not demonstrate burden of blaNDM-1 than had not been previously appreciated. risk of colonization or infection with NDM-1 producers. As the screening rectal swab that was 1-producing K. pneumoniae similarity previous isolates. prompt Struelens et al. reviewed 77 NDM-1 producing Enterobacterisuccessful management of this to outbreak demonstrates, performed at a were isolated from the abscess 25 regional hospital aceae reported from 13 European countries from 2008 to 2010. infection prevention and control practices are essential to Clinical specimens that were km from UHL. This CPE In No week 2015, NDM-1-screening was discharge IV tigecycline 50 mg travel10history, prevent transmission. staff42, or environmental Among 55 of the cases with recorded 31 had positive for NDM-1-producing screen was performed because every 12 h was initiated and the producing K. pneumoniae was educaperformed but extensive resources directed towards involved travel to, or admission to a hospital in, India or Pakistan, Enterobacteriaceae included midtheBalkan patient had been admitted to debrided surgically. The in the isolated by rectal swab from tion, hand hygiene compliance, environmental disinfection, and site five was patients had been hospitalized region. stream urine samples UHL in the previouscleaning 12 months patient died twoacquisition months following screen of a standards an andadmission reducing CPE carbapenem consumption Possible nosocomial accounted for 13 of 77 cases (N � 2), rectal swabs (N � 8), but his last admission tosuccessful UHL hadin controlling admission secondary to refractory patient repatriated from Bosnia. were rapid in-hospital transmission of (17%). In contrast, our outbreak more closely resembled the and skin biopsy samples (N � been five months soft tissue sepsis. NDM-1 before producers. The detection of to additional outbreak reported by Borgia et al. that occurred in almost Brampton, She subsequent had not been admitted 3). NDM-1-producing isolates cases, in particular UHL the related isolate from anever nursing home Ontario, Canada where five patients were identified as carrying the outbreak was declared. previously and had were meropenem resistant with Evolution ofK. the outbreak all of them epidemiologically resident in week 31,had 2015, demonstrates the difficulty NDM-1eproducing pneumoniae; Patient J was identified as CPE any specimensboth processed in of MICs ranging from 12 to 32 26 definitely these once established linked with each other, but none with The patient demographics area relevant travel history. from a urine sampleeradicating the UHLorganisms microbiology laboratory.in the mg/L. All isolates were tigecycline The dominant species in our NDM-1positive ‘revolving door’ systems of nursing homes and hospitals, and outbreakat was summarized in Table I; all were collected a regional hospital In week 48, 2015, NDM-1susceptible (MIC 1 mg/L). One K. pneumoniae (Figure 1). A successfully controlled the fact that these bacteria are becoming more prevalent. outbreak in UHL; permanent Irish residents. 40 km away from this producing E. coli was detected isolate was colistin-resistant (MIC Mexico City reported the isolation of NDM-1-producing E. coli During the outbreak, our routine was determined by PFGE in a 60-year-old patient who had 4.0 mg/L; mcr-1 gene negative). and NDM-1-producing E. cloacae from the isolate same patient in screening programme was (Figure 1) to be the Acknowledgements isolate most been recently hospitalized in India PFGE demonstrated that the K. addition to three NDM-1-producing K. pneumoniae isolates extended to include weekly distantly related to the other (Figure 2). Again, these isolates pneumoniae isolates were closelyderived from three other epidemiologically-related patients. In We thank the staff of the Microbiology Laboratory at UHL for testing of rectal swabs or outbreak isolates. did not demonstrate similarity to related (Figure 1). Multilocus that outbreak, one plasmid (IncFII) was borne by all of the their expertise in successfully dealing with this outbreak, E. stool specimens from patients sequence typing (MLST) was the outbreak strain. isolates.27 In a large outbreak reported from South Africa (as in McGrath for performing pulsed-field gel electrophoresis at Given the identification of NDM-1 and hospitals), which our with case,epidemiological also from three acute persisted for not performed. University Hospital Galway, and S. Guilfoyle, medical secretary at dominant three different environmental to confirmed Discussion 16 weeks in 2012, K.links pneumoniae was also the spe- associated at was the UHL Department of Clinical Microbiology, for assisting CPEpositive patients. CPE hospitals, a decision made cies and accounted for 28/38 isolates (74%) with E. cloacae Index case Thecharts. source of the index patient’s review screening was5/38 performed to perform contact with tracing andof medical accounting for the (13%).28 for a The index case was a NDM-1-producer acquisition

period of four weeks after no screening of all contacts at each community-dwelling Irish female. remains uncertain although Conflict of interest statement new cases CPE colonization or site. As a result of thatNone exercise, from of the outbreak In the summer of 2014, she was Learning declared. acquisition during the hospital infection had been detected. during the outbreak, 2204 CPE admitted with sepsis. Blood and admission of June 2014 is reported substantial community reservoirs screens, including contact tracing peritoneal fluid cultures confirmed In 2013, Lin et al. Funding sources considered likely. The index case 29 In June 2014, two contacts of CPE in the USA. Currently, there are no data available in and routine CPE screening, were This study was funded in part an Irish Societyfor of Clinical E. coli. Initial admission was to a had been onbyhaemodialysis 16 regarding prevalence long-term in care of the index national case prior to her of CPE in processed our laboratory, Microbiologists research bursary, which is supported by six-bed bay in a general medical Ireland years and switched to peritoneal facilities (LTCFs) as a national point prevalence study of LTCFs ICU admission were identified which in addition to detecting the Pfizer Ireland. ward preceding transfer the dialysis in 2013 (five months relating to multidrug-resistant has NDM-1 never been per- also identified (patients B, D). Both hadorganisms been isolates, following day to a single room prior to NDM-1 detection). In our formed. However, three of the ten patients in this outbreak were on the medical ward with the 13 new KPCs and one OXA-48. in the intensive care unit (ICU). References care, all haemodialysis patients permanent residents of three separate LTCFs (two public, one index case during her 24 h Admission screens confirmed undergo surveillance CPE private) and one other patient was a permanent resident in a admission before transfer to Carbapenem consumption 1. Gupta N, Limbago BM, Patel JB, Kallen AJ. Carbapenem-resistant prior colonization with meticillin- residential care facility for adults with learning disabilities screening every three months, ICU. Patient B was screened, Only the index case had been Enterobacteriaceae: epidemiology and prevention. Clin Infect Dis resistant Staphylococcus aureus (Table I). Such a study is needed, justified by our data and the but the same screening is not 2011;53:60e67. as NDM-1-producer prescribed meropenem during (MRSA) and vancomycin-resistantfactidentified that, between 2009 and 2015, 140 CPE isolates were idenforetperitoneal 2. Sekizuka T, Matsuiconducted M, Yamane K, al. Completedialysis sequencing of positive and was isolated. Patient the current admission; the Enterococcus faecium (VRE). A tified from clinical specimens of which 12 CPE isolates originated the bla(NDM-1)-positive IncA/CThe plasmid from Escherichia coli ST38 patients. index case patient D was discharged prior to CPE patient had received five days of rectal screen at that time did not in local public (N ¼ 10 isolates) and private (N ¼ 2 isolates) isolate suggests a possible origin from plant pathogens. PLoS One was screened for rectal CPE 30 screening. She re-presented for meropenem before the2011;6:e25334. isolation detect CPE. Empiric therapy LTCFs. in December 2013, at which admission in July 2014 and was of an NDM-positive culture. used intravenous (IV) ceftazidime time CPE was not detected. re-admitted to a six-bedded 2 g every 8 h and gentamicin. Please cite this article in press as: O’Connor C, etNDM-1 al., An Irish outbreakidentified of New Delhi metallo-b-lactamase carbapenemase-producing Following(NDM)-1 her transition to isolates area on the same medical ward As she did not respond to Enterobacteriaceae: increasing but unrecognized prevalence, Journal of Hospital Infection (2016), http://dx.doi.org/10.1016/ peritoneal dialysis, no further CPE post outbreak to which she had been admitted initial therapy, treatment was j.jhin.2016.08.005 screening was performed prior In week 31, 2015 (i.e. 10 months in June 2014. CPE screening changed to meropenem 1 g to her transfer to ICU on this final after the 2014 outbreak ended), confirmed that she was NDM-1IV every 8 h, metronidazole NDM-1-producing K. pneumoniae admission to UHL, at which time producer positive and she was 500 mg IV three times per day CPE was likewise undetected. was identified in an mid-stream isolated immediately. Patients E, and vancomycin 1.5 g IV every She had never worked in a urine sample from an 81-year-old F, and H were ward contacts of 12 h but was deescalated to healthcare setting nor lived with female residing in a private longthe index case, and patients G meropenem monotherapy. any healthcare workers. She term care facility (LTCF). This and I were identified from routine patient was a contact of the index had no known travel to NDM-1 admission rectal CPE screens Seven days post admission, case during the outbreak but CPE endemic areas. a rectal CPE screen (routine performed during the outbreak

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.


CPD 25: Gram Negative

Table I Clinical characteristics of patients involved in an outbreak of New Delhi metallo-b-lactamase-1 (NDM-1) carbapenemase-producing Enterobacteriaceae Patient

Age Sex (years)

Place of residence

A

44

F

Community

B

78

F

Community

C

61

M

Community

D

65

F

Residential care facility

E

81

F

Public LTCF

F

71

F

G

89

F

H

90

F

Community

I

75

M

Public LTCF

J

53

F

Community

Date admitted

Admitting diagnosis

Week 24 Peritonitis (2014) Week 24 Streptococcus (2014) milleri bacteraemia Week 25 Urinary (2014) retention

Treated with meropenem during admission

Yes No

Specimen

Organism(s) isolated

Rectal swab Klebsiella pneumoniae Mid-stream K. pneumoniae urine

Carbapenemase enzyme(s) detected

NDM-1 NDM-1

No

Rectal swab K. pneumoniae

NDM-1

No

Rectal swab K. pneumoniae

NDM-1

Respiratory infection Collapse

No

Rectal swab K. pneumoniae

NDM-1

No

Rectal swab K. pneumoniae

NDM-1

Congestive cardiac failure Week 30 Respiratory (2014) infection Week 35 Respiratory (2014 infection Week 37 Skin and (2014) soft tissue infection

No

NDM-1, KPC

No

Rectal swab Escherichia coli, Enterobacter cloacae Rectal swab K. pneumoniae

No

Rectal swab K. pneumoniae

NDM-1

No

Mid-stream urine

NDM-1

Week 30 Urinary (2014) infection

Week 30 (2014) Community Week 30 (2014) Private LTCF Week 32 (2014)

K. pneumoniae

NDM-1

Date of culture

Infected/ colonized

Outcome

Week 25 Infected Died (2014) Week 25 Colonized Discharged (2014) to LTCF

Previous admission to hospital in previous 12 months

Yes Yes

Week 25 Colonized Discharged (2014) to the community Week 32 Colonized Discharged to (2014) residential care Week 32 Colonized Discharged (2014) to LTCF Week 32 Colonized Discharged (2014) to LTCF Week 33 Colonized Discharged (2014) to LTCF

Yes

Week 33 Colonized Died (2014) Week 35 Colonized Discharged (2014) to LTCF Week 37 Colonized Discharged (2014) to the community

No

Yes

Yes Yes Yes

No

C. O’Connor et al. / Journal of Hospital Infection xxx (2016) 1e7

No

LTCF, long-term care facility; KPC, Klebsiella pneumoniae carbapenemase.

In this outbreak, international travel was not a recognized factor, implying that there may be a hospital and/or community burden of blaNDM-1 than had not been previously appreciated. Struelens et al. reviewed 77 NDM-1 producing Enterobacteriaceae reported from13 European countries from2008 to 2010.25 Among 55 of the cases with recorded travel history, 31 had involved travel to, oradmission to a hospital in, India or Pakistan, and five patients had been hospitalized in the Balkan region. Possible nosocomial acquisition accounted for 13 of 77 cases (17%). In contrast, our outbreak more closely resembled the outbreak reported by Borgia et al. that occurred in Brampton, Ontario, Canada where five patients were identified as carrying NDM-1eproducing K. pneumoniae; all of them epidemiologically linked with each other, but none with a relevant travel history.26 The dominant species in our NDM-1 outbreak was K. pneumoniae (Figure 1). A successfully controlled outbreak in Mexico City reported the

isolation of NDM-1-producing E. coli and NDM-1-producing E. cloacae from the same patient in addition to three NDM-1producing K. pneumoniae isolates derived from three other epidemiologically-related patients. In that outbreak, one plasmid (IncFII) was borne by all of the isolates.27 In a large outbreak reported from South Africa (as in our case, also from three acute hospitals), which persisted for 16 weeks in 2012, K. pneumoniae was also the dominant species and accounted for 28/38 isolates (74%) with E. cloacae accounting for the 5/38 (13%).28 Learning from the outbreak In 2013, Lin et al. reported substantial community reservoirs of CPE in the USA.29 Currently, there are no data available in Ireland regarding national prevalence of CPE in longterm care facilities (LTCFs) as a national point prevalence study of LTCFs relating to multidrugresistant organisms has never been performed. However, three of the ten patients in this outbreak were permanent residents of three separate LTCFs (two public, one private) and one other patient was a permanent resident in a

residential care facility for adults with learning disabilities (Table I). Such a study is needed, justified by our data and the fact that, between 2009 and 2015, 140 CPE isolates were identified from clinical specimens of which 12 CPE isolates originated in local public (N � 10 isolates) and private (N � 2 isolates) LTCFs.30 Influenced by this outbreak, our antimicrobial stewardship has been modified. Overall hospital antibiotic consumption rate in defined daily doses (DDD) per 100 bed-days used (BDU) demonstrates a reduction in carbapenem consumption. Between 2014 and the end of 2015, carbapenem consumption decreased by 21% (2014: 4.43 DDD/100 BDU, 2015: 3.49 DDD/ 100 BDU). This compares very favourably with a 4% increase from 2013 (4.24 DDD/100 BDU) to 2014, 25% increase from 2012 (3.39 DDD/100 BDU) to 2013, a 36% increase from 2011 (2.50 DDD/100 BDU) to 2012.30 In conclusion, this outbreak and our other sporadic isolates indicate the changing epidemiology of NDM-1 CPE. In Ireland, as elsewhere (e.g. Canada), a history of travel to

a known endemic area is of decreasing value in identifying persons at risk of colonization or infection with NDM-1 producers. As the successful management of this outbreak demonstrates, prompt infection prevention and control practices are essential to prevent transmission. No staff or environmental screening was performed but extensive resources directed towards education, hand hygiene compliance, environmental disinfection, cleaning standards and reducing carbapenem consumption were successful in controlling rapid in-hospital transmission of NDM-1 producers. The subsequent detection of additional cases, in particular the related isolate from a nursing home resident in week 31, 2015, demonstrates both the difficulty of definitely eradicating these organisms once established in the ‘revolving door’ systems of nursing homes and hospitals, and the fact that these bacteria are becoming more prevalent. References available on Request.

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.

5

Please cite this article in press as: O’Connor C, et al., An Irish outbreak of New Delhi metallo-b-lactamase (NDM)-1 carbapenemase-producing

30


Awards Hospital Professional

Awards 31

2016

Celebrating Excellence and Innovation Hospital Professional Awards 2016

The fourth Hospital Professional Awards took place on Saturday, September 17th in the Hilton DoubleTree Hotel, Dublin.

been driving benefits to both clinical peers and patients with the objective of greater shared outcomes.

The success of the HPN Awards has driven further growth as this year we opened our entry process to encompass the greater hospital team, to now include Consultants, Specialists and clinical teams in addition to our leading base of hospital Pharmacists.

Dr Ambrose McLoughlin, former Secretary General to the Department of Health, Chief Executive of the Pharmaceutical Society of Ireland and current Chairman of the Heartbeat Trust added, “I am a huge supporter of excellence in healthcare and excellence amongst healthcare professionals.

The Hospital Professional Awards offer a unique programme to bring these leading professionals together to showcase the ongoing projects currently being undertaken throughout Ireland's hospitals to disseminate results, promote learning and best practice so that the excellence in specialist work is shared in every hospital setting in Ireland. There were thirteen extremely deserving winners crowed on the night for categories ranging from the coveted Hospital Pharmacist of the Year and Oncology Pharmacist of the Year to the Young Hospital Professional of the Year and the Innovation & Service Development Award. Stephen McMahon, Founder of the Irish Patients Association and PACT for Patient Safety said, “I believe events such as the Hospital Professional Awards are hugely important as they illustrate and showcase the best approaches amongst many stakeholders in our healthcare service for providing better and safer care for patients. “Often in the media we hear the negative stories about what has gone wrong, but Awards such as these recognise the very hard work being carried out by healthcare professionals on the front line.” Investing in the further development of secondary care within Ireland, the education and clinical learning derived from entries to the Hospital Professional Awards will highlight the quantifiable projects that have

“Pharmacy and medicine are hugely important for patients, we really want to inspire them to maintain a level of excellence that delivers the very best outcomes for patients. “Our health system has had many challenges, we have come through a major crisis in our health service over the last number of years and we are coming out of that now, but the key people that really matter are the patients and those professionals on the front line who look after them. “Without their support, and without their excellence and without their commitment, patients would not benefit. “I am here to support them to get the recognition they deserve and to insure that not only do they get recognition but that they inspire and lead their colleagues into the future to do something really important which is to provide the best care possible, in the right circumstances and at the right time for the patients that we all serve.” Turn the page for all the details of this year’s highly deserving thirteen category winners. The December issue of Hospital Professional News will carry in-depth case study profiles of each winning entry alongside our annual Hospital Top 100 Professionals so don’t miss it!

We must support hospital professionals to get the recognition they deserve and to insure that not only do they get recognition but that they inspire and lead their colleagues into the future to do something really important which is to provide the best care possible, in the right circumstances and at the right time for the patients that we all serve. - Dr Ambrose McLoughlin, former Secretary General, Department of Health & Chair, Heartbeat Trust HPN • October 2016


Awards 32 Awards

Hospital Professional

2016

Idis Hospital Pharmacist of the Year 2016

Part of the Clinigen Group

Michael Fitzpatrick from Our Lady’s Children’s Hospital, Crumlin took home the Idis Hospital Pharmacist of the Year Award title for 2016 at the recent Hospital Professional Awards ceremony. He was presented with the accolade due to his exceptional skills as a Lead Pharmacist, evident from the respect and hard work that is seen from his staff, colleagues and peers. Michael is currently Head of Pharmacy Services at OLCHC and Pharmacy Lead for the new National Children’s Hospital. He joined the pharmacy team in Crumlin ten years ago and in that time he has accomplished a vast amount both within and outside of the hospital setting. He has been the leading figure on a number of major changes in the department and within the paediatric hospital circuit.

Michael Fitzpatrick, Head of Pharmacy Services, Our Lady's Children's Hospital Crumlin with Anna Ryan, Key Account Manager for Ireland, Idis

Michael Fitzpatrick, Head of Pharmacy Services, Our Lady's Children's Hospital, Crumlin

Having previously worked as a Pharmacy Technician; followed by some time in the private hospital sector and then eventually evolving to his role as the Head of pharmacy services in OLCHC, he has brought his wealth of expertise to his current role in a number of different manners. He has been a crucial and influential figure in the introduction and maintenance of the OLCHC formulary app, which has enabled safer and better access to paediatric doses and providing all healthcare professionals with easy access to this information. His exceptional IT skills combined with being an eagle-eyed Pharmacist make the perfect candidate to undertake the huge projects with which he has been involved. The new Children’s Hospital is a huge project in which Michael has been involved with since the get-go. It is his determination and fight to ensure that He has been involved from the development stage with this project. More recently he has been appointed to the National Children’s Hospital Board as the Pharmacy Lead. October 2016 • HPN

Michael will most certainly ensure that pharmacy services are at the forefront of the new hospital taking into consideration providing a diverse clinical service; world class compounding service; and developing an outpatient service for paediatrics. Speaking after receiving his award Michael says, “I am really delighted to have won this Award tonight. It is great to be recognised as a smaller, more specialised service that is paediatrics. We do a tremendous amount of work and sometimes it can get slightly overlooked by the excellent

work being carried out by the larger hospitals. “We are however coming more to the fore as technology changes and clinical demands change; we are becoming much more important to the wider healthcare agenda. These Awards really give people the empowerment to achieve more, what is next? The future is exciting.” Key Account Manager for Ireland with Idis, Anna Ryan commented, “This is our third year sponsoring the Hospital Pharmacist of the Year Award and we are very

privileged to be a part of these Awards. Everything tonight is positive what is we doing right, what is helping, what is working. Promoting excellence within hospital pharmacy is something that we are passionate about at Idis. “One of our taglines within the Clinigen Group is that we don’t see problems, we only see solutions and that is very evident tonight. For the nominees, finalists and guests here tonight, there are no problems, they are providing solutions for patients and patient care all the time.”


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Awards 34 Awards

Hospital Professional

2016

HPN Young Hospital Professional of the Year 2016

The HPN Young Hospital Professional of the Year Award went to Pharmacist Dearbhla Murphy from the Mater Misericordiae University Hospital.

Dearbhla Murphy, Clinical Pharmacist, Pharmacist, Mater Misericoridae University Hospital

Dearbhla works in the Pharmacy Department at the Mater Misericordiae University Hospital (MMUH). Upon qualification as a Pharmacist in 2013, she has been working in the speciality of Oncology for the past two years. Dearbhla works half time as a Clinical Pharmacist alongside her role in the Aseptic Compounding Unit. Dearbhla has been described as ‘an ambitious, driven and hard-working individual. She loves working as part of a team. Dearbhla is popular with staff and patients alike. Dearbhla is enthusiastic and dedicated to her role in Oncology, always striving to improve the Oncology Pharmacy service for the better of her patients.’ She has demonstrated exceptional leadership in her roles. Her leadership is aligned with being an active part of the team, communicating and respecting others’ opinions, listening, and recognising opportunities for interventions and service development. An example of this is Dearbhla’s attendance at the Oncology multidisciplinary team meetings. During these meetings Dearbhla advises the Consultants on treatment doses, patient progress, toxicity management and drug interactions. Her role as a Clinical Pharmacist involves daily interaction with the multidisciplinary team to provide a quality Clinical Pharmacy service to patients in the MMUH. Adds her nominee, “Most people aren’t typically thought of as leaders in the workplace early in their careers, and it is often difficult for young professionals to assume a leadership role. In Dearbhla’s case, the right attitude, hard work and a desire to learn have demonstrated her leadership capabilities and there is no doubt that Dearbhla will continue to October 2016 • HPN

Dearbhla Murphy, Clinical Pharmacist, Mater Misericoridae University Hospital and Kelly Jo Eastwood, Editor, Hospital Professional News

develop pharmacy services, both within her speciality and beyond throughout her career.” After receiving her award Dearbhla commented, “It is really fantastic to be acknowledged with this Award. It has been one thing to be shortlisted and nominated and another to win. “For me the greatest recognition came with being nominated and shortlisted. Internally, it shows that your manager/employer would value you enough to put you forward; so that was the biggest achievement for me.

“The category this year has been incredibly strong, with 2 very and equally deserving winners so I am truly delighted to have been awarded the title of Young Hospital Professional of the Year and I would like to thank Hospital Professional News for their organisation in the awards process overall and for recognising the worth of those entering the profession and beginning their career.” Kelly Jo Eastwood, Editor of Hospital Professional News congratulated Dearbhla on her award stating, “Young hospital professionals such as Dearbhla

truly are the rising stars of the healthcare arena and we are delighted to be associated with this category, which recognises the achievements of those at the start of their career path within the hospital setting. “Dearbhla is an extremely deserving recipient of this accolade for her endeavours on her way to the top of her profession, encouraging her colleagues and helping to maximise the skills of her team as she works towards truly unleashing all her potential.”


Awards Hospital Professional

35

2016

Multidisciplinary Award 2016

The Multidisciplinary Award was won by the Pharmacy team at Beaumont Hospital. Treatment of patients is, in most cases, a combined effort of several individuals and it is recognised that the outcome of a procedure is optimal when the professionals do indeed work together as a team. The team at Beaumont displayed that and more with their entry which focused on their hospital development project, which commenced in 2015. The focus was on the elderly, the highest numbers of patient admissions and provision of care at Beaumont for the Pharmacy Department. The initiative and challenge was to innovate, initially with the current staff, change their service for the elderly, improving the quality of care provided, in particular, to the FRAIL elderly in the Emergency Department (ED). The professional teams met regularly in the summer of 2015 to unravel the sequence of steps a FRAIL elderly patient may go through on arrival at the ED. Complex older patients are less likely to be discharged from the acute medical services having significantly longer length of stay in hospital if admitted. The team recognised the need to identify these patients and develop an improved service where the patient’s rehabilitation intervention commences in the ED. Hence a team of Health and Social Care professionals were allocated to work in ED determining suitability for, amongst others, community services and day hospital review. All professions dedicated resources on the Frail Elderly ward, ED and Day Hospital where possible in spite of a lack of staff for many months. The results of the impact, made by all professions, even if the measurement was for a short period of time, dramatically showed the enormity of the collective addition and quality improvement to patient care when dedicating resources in a united way.

Beaumont Hospital Pharmacists Ciara Reddy, Mairi Donald, Nuala Doyle, Anne Marie Garvin and Joanna Carroll

Beaumont Hospital saw 34 less deaths in the first quarter of 2016 in those ages 74+. There were 36 less deaths in the whole emergency medical admission cohort but improvement is due to this 75+ age group. The next stage for the plan is currently under way with core ward model with MDT and associated pathway development. Nuala Doyle, Head of Pharmacy Services at Beaumont Hospital, commented, “We are over the moon to receive this Award, which we see as magnificent recognition of am innovation we began this time last year. This was when allied health professional got together within our hospital including social work department, physiotherapy,

speech & language therapy, occupational therapy, dietetics and pharmacy and pulled all our resources together in our services to the care of the elderly. “We met our elderly, the frail elderly in particular, at the hospital front door and focused all of our specialisms towards them to make their journey through the hospital the best we could. Our aim has been to give them an extremely good quality of life depending on their needs. We address their needs and ensure their hospital stay is as short as possible. “To win an Award like this has proven to us all the hard work we have striven to do over the last year has been worthwhile.”

Nuala Doyle, Head of Pharmacy Services, Beaumont Hospital

HPN • October 2016


Awards 36 Awards

Hospital Professional

2016

Daiichi Sankyo Hospital Pharmacy Team of the Year Award 2016

The coveted title of Daiichi Sankyo Hospital Pharmacy Team of the Year went to Tallaght Hospital Pharmacy Department in a hotly contested affair which saw no less than eight shortlisted finalists from over 30 submissions received. There are many key elements to building a productive team, including communication and cooperation. Good communication means everyone is aware of their own responsibilities and what the team's goals are whilst co-operation leads to increased productivity. The team from Tallaght have all been involved in the introduction of a Medicines Management Technician (MMT) Service in Tallaght Hospital. In January 2015 the decision was made to introduce the MMT service to one ward in the hospital. Prior to the introduction this service, each ward carried a range of medications as ward stock. Nursing staff ordered non-stock medicines which were supplied to the wards as a 7 day supply labelled with the patient’s details. The MMT’s role was to ensure that medicines were ordered, supplied and managed effectively at ward level. In order to facilitate this, medication was dispensed as original packs. The turnaround time for each item in the dispensary has been reduced from 4mins 30sec to 11 sec. It is this efficiency that has generated the time to provide the MMT service to the wards without any additional staffing resource. The service is now available on 8 of the adult inpatient wards with full roll out due for completion by year end. This service has reduced the burden of medication ordering for nursing staff who now have more time for direct patient care. It makes better use of the skill set of both Pharmaceutical technicians and nurses and has led to improvements in communication October 2016 • HPN

The Pharmacy Department from Tallaght Hospital pictured with Elizabeth Kehoe, Senior Brand Manager with Daiichi Sankyo, Ireland

The Tallaght Pharmacy Team pictured with Elizabeth Kehoe, Senior Brand Manager, Daiichi Sankyo between nursing and pharmacy staff, advanced roles for pharmaceutical technician’s, generated efficiencies within the system and reduced the risk of missed doses for our patients. The team are motivated to ensure that the patients in Tallaght Hospital receive the best possible pharmaceutical care in a timely manner. They have all strived to make the new MMT service the success that it has become. All team members share this common goal and work together to stay motivated and achieve these outcomes. Team meetings and individual meetings with staff help to keep all motivated, and allow feedback on the service as

it develops. Future developments to the services provided are being planned including assessment of patients own medications. Pharmacy Manager with Tallaght Hospital John O’Byrne said, Imelda Corcoran, Medicines Management Technician at Tallaght Hospital spoke on behalf of the team. She said, “Every member of our team has a specialist skill that they bring to the table. We all work together to ensure our service offering and patient care is at the highest possible level. “As a whole unit, we feel fantastic to gain recognition and acknowledgment for the work we have carried out together, this is such a major achievement for the

Pharmacy and serves to let us know what we are doing is right. We will continue to work as hard as we have been to ensure its our patients that benefit.” Elizabeth Kehoe, Senior Brand Manager with Daiichi Sankyo, Ireland said, “This is the first year that Daiichi Sankyo have supported these Awards and we are delighted to do so. We are an innovative company and one which focused on supporting and education and innovation which is crucial within the workings of any excellent team. We are very proud to be associated with the Hospital Pharmacy Team of the Year Award and offer many congratulations to Tallaght Hospital.”


Awards 38 Awards

Hospital Professional

2016

Excellence in Patient Safety Award 2016

Hospital professionals are continually striving to find new ways to improve patient care. This Award sought to recognise those who have shown commitment and dedication to improving patient safety/medication safety amongst patients in the secondary care setting.

Moninne Howlett, Chief II Informatics Pharmacist with Our Lady’s Children’s Hospital, Crumlin and Mr Stephen McMahon, Founder, Irish Patient's Association and PACT for Patient Safety

On the night, the Award went to Moninne Howlett, Chief II Informatics Pharmacist with Our Lady’s Children’s Hospital in Crumlin and her team, who were celebrated for their work with critically ill paediatric patients. Critically ill paediatric patients are a vulnerable cohort of patients at high risk of medication error. The risks in preparing paediatric and neonatal infusions have been specifically addressed over the last 15 years. Recommendations include the replacement of traditional individualised weightbased infusions with standard concentration infusions (SCIs) and the use of smart-pump technology. Wide scale implementation of these have been advocated by the Joint Commission on Accreditation of Healthcare Organisations (JCAHO) and international safety agencies. Despite this uptake has been slow, with implementation rates in Europe falling far below those in the US. In 2012, Our Lady’s Children’s Hospital Crumlin (OLCHC) developed and implemented a smart-pump drug library of paediatric SCIs into their paediatric intensive care unit (PICU), operating theatres and cardiac ward. A few months later, a clinical management content system (CIMS) was introduced into the PICU. A further safety initiative was to integrate the smartpumps with the CIMS. A range of ‘standard orders’ or prefilled electronic prescriptions were created for each SCI. In late 2014, the Irish Paediatric Acute Transport Services (IPATS) was commissioned and was to be run out of the PICUs in both OLCHC and Temple Street Children’s University Hospital (TSCUH). With October 2016 • HPN

The team from Our Lady's Children's Hospital including Chief Pharmacist Michael Fitzpatrick and Moninne Howlett, Chief II Informatics Pharmacist

the current resource restraints in the Irish health service, and critically ill children’s safety being paramount, a decision was made to standardise practices and align all sites with best practice recommendations. Further plans are to extend the use of the paediatric SCI library to paediatric patients cared for in adult intensive care units or regional hospitals, or during stabilisation prior to transport to a PICU. Speaking after receiving the award Moninne said, “This project involved the clever use of technology to improve patient safety for a vulnerable group of patients that are very ill. It was a collaborative piece of work carried

out within our own hospital and with other paediatric hospitals and the maternity hospitals. “When you work as hard as we do behind the scenes, in a very resource limited environment, it is fantastic to get the opportunity to work collaboratively and therefore maximise our use of resources for the benefit of the children. “We feel very honoured to be recognised for our work with this Award tonight which I am happy to accept on behalf of the entire team as it is truly a multidisciplinary effort.” Presenting the award on the night was Mr Stephen McMahon, Founder of the Irish Patients Association and PACT for Patient

Safety. He told us, “I believe events such as the Hospital Professional Awards are hugely important as they illustrate and showcase the best approaches amongst many stakeholders in our healthcare service for providing better and safer care for patients. “Often in the media we hear the negative stories about what has gone wrong, but Awards such as these recognise the very hard work being carried out by healthcare professionals on the front line. “We at the Irish Patient’s Association are very proud to be a part of this as we also have the PACT for patient safety, which we initiated two years ago and is now signed by some 29 patient groups throughout the EU.”


Awards Hospital Professional

39

2016

Hospital Specialist of the Year 2016

A first and new Award for 2016, the Hospital Specialist of the Year title went to Sarah Molony, Deputy Clinical Pharmacy Service Manager with the Mater Misericordiae University Hospital.

Sarah Molony, Deputy Clinical Pharmacy Service Manager, Mater Misericordiae University Hospital

Speciality clinicians are essential components of service provision, providing a major share of the medical input in many teams. This award looked for a Specialty Clinician who has demonstrated advanced clinical skills as well as excelling in service development, teaching, research and leadership. Sarah was unable to attend the Awards evening and so the Award was accepted on her behalf by Jennifer Brown, Pharmacy Head of Operations at MMUH. Sarah Molony has worked as a clinical pharmacist within MMUH since March of 2012 and during that time has made huge contributions to the enhancement of patient care within the Pharmacy department. She has worked as the Emergency Department and Ophthalmology Pharmacist since January 2015.

Jennifer Brown, Pharmacy Head of Operations, Mater Misericordiae University Hospital who accepted the Award due to Sarah's absence

The Mater Misericordiae University Hospital is a tertiary care ophthalmology centre which treats complicated ophthalmological conditions. Extemporaneous eye drops are required to treat acute ophthalmic conditions when a commercial alternative is not available. When patients being treated with extemporaneously compounded eye drops arte being discharged, the MMUH Ophthalmology Pharmacist liaises with the patients’ community pharmacies, providing aseptic preparation guidelines, individual eye drop protocols and a manufacturing pack. Additionally, Sarah ensured that these protocols were available on the hospital intranet for nursing and medical colleagues as required, in the eventuality that extemporaneous eye drops are required to be made out-of-hours. In collaboration with the Dispensary Service Manager, Sarah firstly reviewed and updated

the extemporaneous eye drop protocols and aseptic preparation guidelines to ensure that they were easily understood and up to date.

Her work has also aided the provision of a useful educational tool which also impacts greatly on patient care.

One nominee described her as ‘an innovative Clinical Pharmacist who has the ability to identify where service development can be achieved and determines how best to achieve this.’ Her work as an Ophthalmology Specialist has greatly enhanced the provision of patient care within the MMUH for patients and importantly for those patients upon discharge.

Sarah is someone who works well with her colleagues both in the Medical, Nursing and Pharmacy departments and develops excellent working relationships, acknowledging the strength of her colleagues. Accepting the Award on her behalf, Jennifer Brown commented, “Sarah is one of our younger Pharmacists who

has just completed her Masters and who has completed a great deal of excellent work within the ophthalmology specialist field recently. This Award serves as great recognition for this work that she has done not only for her patients but for both hospital pharmacists and community pharmacist colleagues. I am delighted to accept this Award on her behalf just as I know she will be equally proud to hear she has won it.”

HPN • October 2016


Awards 40 Awards

Hospital Professional

2016

Actavis Innovation in Aseptic Compounding Award 2016

The Actavis Innovation in Aseptic Compounding Award for 2016 went to the Aseptic Compounding Unit at the University Hospital Limerick. The Cancer Centre at University Hospital Limerick is one of eight designated centres of excellence for cancer treatment in the country. The Aseptic Compounding Unit (ACU) at UHL manufactures individually tailored chemotherapy and biological preparations for patients attending UHL for cancer treatment and is fully equipped with modern isolator technology in a clean room environment. The unit is staffed by qualified and trained Pharmacists and Pharmacy technicians with the objective to continually provide a safe, efficient and high quality service to their patients and other service users. At the University Hospital Limerick, Cancer Services, the workload is continually increasing, this manifests as an increase in the number of chemotherapy prescriptions to be prepared in Pharmacy. The team try to ensure work is done as quickly and as efficiently as possible, not wanting to over-look the importance of continually providing the highest of standards in safety and quality control in their manufacturing processes. It was deemed important that the team implement a plan to help alleviate some of the pressures of these increased demands on the service. Having had a team member who had just completed a course in Lean Management systems, they discussed this principle and decided to embrace the principles of lean management in the A.C.U. The team devised a standardised system that the trays were taken out the evening before and the priority treatments were put in first along with any treatment that could be made in advance. The patient diary would then be October 2016 • HPN

Joanne Nally, Michelle English, Rita Sweeney, Ann O'Flynn, Barbara Kavannagh, Marie O'Grady and Mr Conor Sadlier, Key Account Manager, Actavis Ireland

Joanne Nally, Oncology Pharmacist and team from University Hospital Limerick Aseptic Compounding Unit denoted with a marking system that everyone could understand. All prescriptions were endorsed by the pharmacist at the dispensing stage. The work flow and rate of production time increased within the unit due to time saving. These efficiencies added value to pharmacist and technician's duties which further allowed the team to accommodate an increased number of patient doses.

working on a Lean Management project to try and increase our efficiencies across the unit and ultimately deliver fantastic patient care to our service users, the patients receiving chemotherapy.

Accepting the Award, Joanne Nally said, “Within our unit at University Hospital Limerick we try and do something annually that is innovative, and this year it was

Mr Conor Sadlier, Key Account Manager with Actavis Ireland added, “We have supported the Aseptic Unit Award since the inception of this event some

“We are a dynamic and innovative team and are delighted to accept this Award. We would also like to thank Actavis for their continued support of this industry.”

four years ago and decided this year to change the title slightly to the Innovation in Aseptic Compounding Award. “We did this to recognise the innovative work that is being carried out in aseptic compounding units in Ireland and to recognise the hard work and dedication to patient safety that is going on behind the scenes”. “There were three excellent shortlisted candidates up for the title this year, and for the second year in a row it was won by the team at University Hospital Limerick. A huge well done to Olivia, Joanne and the team.”


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2016

Consultant-Led Team of the Year Award 2016

This was a new Award for 2016 which served to recognise the hospital team which demonstrates the best combination of team spirit and enhancement of patient care at all levels.

Dr Oisin O'Connell, Consultant Medical Lead, Mater Misericordiae University Hospital with Dr Catriona Bradley, Director, Irish Institute of Pharmacy

The key to any successful hospital department is team work and this Award recognises the power and potential of a focused and unified approach to health care initiatives. It was won on the night by Dr Oisin O’Connell and Professor Jim Egan, Consultant Medical Leads with the Mater Misericoridae University Hospital for their work in lung transplantation. The Lung transplant team in the MMUH celebrated a record year in 2015 by conducting a record number of lung transplants, and a number of other “firsts” including the first heart-lung transplant and the first Irish EVLP transplant. The EVLP technique allows more time for the team to assess and manage donated lungs using a machine and therefore gives more patients the chance of receiving the “gift of life”. These advances in the complexity and volume of transplant surgery are only possible with the concerted teamwork of a highly skilled group of professionals. We were very proud to be featured on the Late Late show recently along-side three patients who benefited from unique lifesaving surgery made possible by the multidisciplinary team. When the Irish lung transplant team was formed by Professor Jim Egan in 2005 it was carefully constructed to include the entire range of professions from medical, surgical and allied health. In this way it was already ahead of best practice internationally where such teams are generally nurse and doctor led, and miss out on the expertise of the allied health team. The team have a focus on the well-being of the patient, and, with so many professionals working in unison all elements of patient care are delivered coherently.

Dr Oisin O'Connell, Consultant Medical Lead, Mater Misericordiae University Hospital

The Mater hospital is fortunate in having a highly skilled, internationally renowned team of surgeons who have pushed the surgical boundaries in transplant since the programme inception. The Mater team are renowned for their expertise in performing single lung transplants in pulmonary fibrosis; which is an unmet need internationally. The survival for lung transplants performed in Ireland is among the best in the world. Two papers have been published in the BMJ outlining the MMUH

protocols and strategies. This success has led to numerous patients being referred for transplant from outside the state. Accepting the Award Dr Oisin O’Connell said, “I am delighted to accept this Award on behalf of the heart and lung transplant team at the Mater Misericoridae University Hospital. We are one of the most dedicated teams in the hospital sector but it is a real privilege to be able to work within the field of transplantation in Ireland.

“Transplants change lives, we have the unique opportunity to be able to keep people’s families alve, to keep people together. It is so important in life to give that extra 1% and the transplant team are always going above and beyond as we all recognise the significance of contributing to the lives of our patients. “To win the Consultant-Led Team of the Year Award and to have our work acknowledged in a great honour for the whole team so thank you.” HPN • October 2016


Awards 42 Awards

Hospital Professional

2016

MSD Antimicrobial Pharmacist of the Year 2016

The MSD Antimicrobial Pharmacist of the Year Award was searching to recognise those pharmacy professionals that have displayed levels of excellence and dedication within antimicrobials in Ireland.

Niamh McEvoy, Senior Brand Manager with MSD and Marie Philbin, Antimicrobial Pharmacist, Midland Regional Hospital, Tullamore

Having a dedicated antibiotic pharmacist within the team can ensure better monitoring and compliance with hospital antibiotic guidelines, which are based on good practice and local assessment of microbiology in the hospital setting. For 2016 the accolade went to Marie Philbin, Antimicrobial Pharmacist at the Midland Regional Hospital in Tullamore, a position she has held since 2004 - the longest serving in this role in Ireland. Marie’s initial work in MRHT demonstrated significant cost savings, a trend from broad spectrum to narrow spectrum agents and an accompanying reduction in Clostridium difficile infection. This work was the stimulus for the HSE creation of 20 Antimicrobial Pharmacist positions in hospitals around the country. Marie’s work in MRHT initially involved audit and feedback, education and bedside patient review. Over the years her work has also encompassed guideline development, expenditure and consumption monitoring, quality improvement projects on surgical prophylaxis, implementation of restriction policies, creation of a designated antimicrobial section in the medication chart. Marie is seen in the hospital as an expert in her field and is held in high regard, she is regularly consulted by Consultant Clinicians, is a key member of both the Infection Control Team and the Antimicrobial Stewardship Team. Marie is the Hospital Lead for the management of OPAT which has proven hugely beneficial to the hospital in assisting in reducing bed pressures. While Marie is the Antimicrobial Pharmacist she has also taken the successful lead on various other projects within the Pharmacy Department including LEAN, Accreditation and new medication kardexes for the hospital. October 2016 • HPN

Marie Philbin, Antimicrobial Pharmacist, Midland Regional Hospital, Tullamore She is dedicated to pursing her formal educational qualifications and has obtained an MSc in Clinical Pharmacy with a thesis looking at the impact of the Antimicrobial Pharmacist on antimicrobial consumption data and a Postgraduate Diploma in Healthcare Management. She also successfully completed the HSE 10-day “Management Development Programme”, the US IHI Basic curriculum in Quality Improvement, Leadership & Patient Safety and the ISMP Medication Safety course. Over the years Marie has hosted Antimicrobial Pharmacists new to the role in MRHT and frequently provides guidance, assistance and advice to other Antimicrobial Pharmacists and National Leads in the area of infection. Her interest in education extends to the supervision of various staff members within the Pharmacy Department; Basic Grade Technician completing Clinical Diploma with University of Derby, Intern Pharmacist in 2013,

Pharmacists completing the MSc with Trinity College Dublin. She coordinated our weekly in-house voluntary Pharmacist CPD session from Summer 2007 to 2015. Accepting her Award, Marie commented, “I am extremely delighted to be the recipient of this Award for 2016. This is the first year of this Award category, it is fantastic to see this category is now a part of the Awards in general and so a huge thank you to Hospital Professional News and MSD for that recognition. It is a great tribute to the work of Antimicrobial Pharmacists across Ireland. “I was one of the first Antimicrobial Pharmacist positions to be established in Ireland and on the back of my original work came the creation of twenty antimicrobial posts in the country. From then, year on year there has been the

creation of even more posts, recently within the Maternity Hospital here. “Our work hinges on the key multidisciplinary team which is the infection control team and the pharmacy department itself. We would not be able to do what we do and achieve what we achieve without the participation of the Clinical Pharmacists on the wards.” Senior Brand Manager with MSD, Niamh McEvoy added, “The reason why MSD supported this particular category is down to our long heritage in the field of antibiotics. Antimicrobial Pharmacists play a vital role in the wider pharmacy team and we are very proud to get behind them in helping to recognise this work. We are delighted to be here this evening once again supporting the work of the Hospital Professionals Awards.”


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2016

Innovation & Service Development Award 2016

The winner of the Innovation & Service Development Award was St Patrick’s University Hospital for their work in ‘Optimisation of Lithium Therapy - Exploring innovative ways to provide Medicines Education.’

Dr Ambrose McLoughlin, Chairman, Heartbeat Trust and Clare Butler, Senior Pharmacist St Patrick's University Hospital

The team, led by Senior Pharmacist Clare Butler aimed to to provide a supplementary resource using visual and verbal methods to offer diverse delivery of medicine related information in an efficient and easily accessible multimedia format. Incorporating the NHS England guidance on medicines optimisation, the team explored a cost effective intervention to optimise medicines use and ensure it is deliverable and affordable on the scale required for their target demographic, a large number of service users in rural/urban areas throughout the country. E-learning packages have been incorporated in training and development in a broad range of areas and deliver a high quality interface for patient education without the difficulties associated with geographical barriers to service provision. Following Department of Health recommendations to address and prioritise health literacy when developing educational and information intervention, the core content was reviewed using the National Adult Literacy Agency (NALA) tools to improve readability and understanding of materials and evaluated for readability scores using the Flesch-Kincaid Readability Test. The programme was launched in June 2015 and made available on the website of St Patricks Mental Health Services ( http://www. stpatricks.ie/lithium). The results suggest that providing lithium education through a multimedia format with a combination of visual and verbal methods increased knowledge and understanding of lithium treatment for over 86% of participants and 80% agree that they find it a better information resource than leaflets.

Clare Butler, Senior Pharmacist and Project Lead, St Patrick's University Hospital

The use of e-learning packages is now being considered by the organisation as an education and training resource for employees for Mental Health Commission training and Fire and Safety Training, and further service user education packages may be developed for other medicines. Speaking on behalf of the team was Claire Butler from St Patrick’s University Hospital who said, “I am very proud and humbled to be able to bring this trophy home to the team at St Patrick’s University Hospital, the team will all be delighted. “The most important thing for us as a team is the recognition for all the work we have carried out during the last twelve months. This category in particular had an astoundingly high level of

excellence within our two fellow finalists and so we are very honoured to have won here tonight.” Presenting the Award on the night was Dr Ambrose McLoughlin, former Secretary General to the Department of Health, Chief Executive of the Pharmaceutical Society of Ireland and current Chairman of the Heartbeat Trust. Dr McLoughlin said, “I am a huge supporter of excellence in healthcare and excellence amongst healthcare professionals. “Pharmacy and medicine are hugely important for patients, we really want to inspire them to maintain a level of excellence that delivers the very best outcomes for patients.

“Our health system has had many challenges, we have come through a major crisis in our health service over the last number of years and we are coming out of that now, but the key people that really matter are the patients and those professionals on the front line who look after them. “Without their support, and without their excellence and without their commitment, patients would not benefit. “I am here to support them to get the recognition they deserve and to insure that not only do they get recognition but that they inspire and lead their colleagues into the future to do something really important which is to provide the best care possible, in the right circumstances and at the right time for the patients that we all serve.” HPN • October 2016


Awards 44 Awards

Hospital Professional

2016

Roche Oncology Pharmacist of the Year 2016

The Roche Oncology Pharmacist of the Year Award for 2016 went to Beaumont Hospital Pharmacist Grant Carroll. Described as someone who is always focused on improving patient care, and the patient’s experience, Grant has contributed to the overall care of his patients in a number of ways. He has suggested, and helped to implement efficiencies on the Day Ward, such as rapid infusions of both rituximab and bevacizumab decreasing the length of patient time on the ward. Currently he is heavily involved in an interdepartmental LEAN review of all the processes used to deliver services to oncology and haematology patients in Beaumont Hospital.

Grant Carroll, Chief II Pharmacist, Beaumont Hospital with Mr Adrian McCann, Finance Director, Interim General Manager, Roche Ireland

Grant Carroll, Chief II Pharmacist, Mr Adrian McCann, Roche Ireland and TV3's Colette Fitzpatrick

Grant Carroll joined Beaumont Hospital Pharmacy Department in September 2012, taking up the post of Chief II Pharmacist as Aseptic Services Manager. He had already worked for five years as a Senior Pharmacist in this same specialist area in St Vincent’s Hospital, giving him a sound basis on which to build on in this post. Grant completed his M.Sc focusing on oral chemotherapy while working in St Vincent’s. He continued demonstrating the beneficial role of Oncology Pharmacist’s involvement in this area while in Beaumont Hospital. Grant introduced a verification process for High Tech prescriptions for oral anticancer medicines and the Senior Oncology Pharmacist, which involved a detailed check of each prescription and liaising with Community Pharmacists to ensure the safe use of these high-risk medicines. This service was supported and encouraged by all of the Consultant Medical Oncologists.

Grant has proven his relentless commitment to his profession, his patients (which saw him prepare chemotherapy out of hours in an emergency out of hours and develop a cost saving strategy (approx. ¤15,000 pa) for future out of hours chemotherapy requirements) his department, his staff and has lead and inspired his team with enthusiasm and drive in the last four years.

together to ensure that cancer treatment, and the best in cancer treatment, is delivered to the patients as safely and efficiently as possible.

Grant is committed to the development of the Pharmacy profession, and he is currently a member of the HPAI Executive Committee. He has also served on NCCP Committees in the past and is currently on the Systemic Treatment Programme Steering Committee.

Accepting the Award Grant said, “I guess you could say the field of oncology pharmacy does not have the highest profile, we are a way from the front line so it is terrific to be recognised for the work that we do. It is equally important to recognise that it is all part of a huge team effort; we all work

Mr Adrian McCann, Finance Director and Interim General Manager with Roche Ireland added, “We at Roche ate very proud to be sponsors of this Award category as a company heavily involved in the field of oncology. It is not, as Grant has highlighted, the most prominent of specialist

October 2016 • HPN

“I would like to thank Hospital Professional News for their work in bringing the efforts of the whole hospital industry to the forefront and also Roche, for their continued support in the field of oncology.”

areas but that does not diminish its importance. “When patients are going through their illness, everything is important, and therefore the work that Grant and his team, and others like them, is vital as it is with the ultimate end goal of making everything as easy as possible for the patient. “Grant has carried out some vital work in this field and anything that can reduce the burden on the patient is to be recognised. “Events such as these Awards are a terrific platform from which we can recognise our partners in the industry who facilitate patients and their treatments throughout the year.”


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2016

Shire Excellence in Child Psychiatry Award 2016

Child & Adolescent Psychiatrists Dr Claire Kehoe, Dr Antoinette D'Alton, Professor Fiona McNicholas, Mr Alan Walshe, General Manager, Shire Ireland, Roisin Gowan, Senior Dietician, Una Brennan and Dr Catherine Diskin (SpR)

This was a new Award for 2016 which looked to recognise the pivotal role that psychiatric professionals and teams play in improving or innovating psychiatric services and care for children and adolescents. The Award was won on the night by the Paediatric Eating Disorder Cross-Hospital Working Group at Our Lady’s Children’s Hospital, Crumlin. Senior Dietician and Chair of the Group, Roisin Gowan had recognised the lack of direction for all staff in the acute admission for Paediatric patients with an eating disorder (ED) and in late 2015 contacted multiple disciplines to gather a multidisciplinary approach to developing guidance to the treatment of the acutely unwell patient with an eating disorder. The aim of the project is to develop a cross-hospital (OLCHC-Temple street- National Children’s Hospital Tallaght) multidisciplinary guideline or consensus for the treatment of the acute admission for eating disorders. It is a multidisciplinary approach with cross hospital involvement. There is another link with the United Kingdom, in that Dr Barrett has been asked to sit on the Junior Marsipan Committee in the UK; voicing Irish needs in the development in these guidelines. This project is the first of its kind in the field of eating disorders in child psychiatry. With limited services allocated for child psychiatry as well as a lack of guidance for both community and hospital services, the team felt that it was imperative that they endeavour to

Roisin Gowan, Senior Dietician, Our Lady's Children's Hospital, Crumlin with Mr Alan Walshe, General Manager, Shire Ireland

develop clear-cut and a consistent approach to the treatment of vulnerable adolescents with eating disorders. Speaking on behalf of the team, Roisin Gowan, Senior Dietician and Chair of the Group who commented, “It is a privilege to be able to accept this Award. Our project is a collaboration of three hospitals; Tallaght Hospital, Temple

Street Hospital and Our Lady’s Hospital Crumlin. “I am delighted to accept this Award on behalf of the teamwork behind its success. Quite often we as professionals can be immersed in our daily work in enhancing the care of our patients and streamlining services for our colleagues and peers that the quality does not get recognise

“It is a tremendous feeling to have this work acknowledged by the industry as a whole and to be recognised as a provider of excellence.” Presenting the award on the night was Mr Alan Walshe, General Manager with Shire Ireland.

HPN • October 2016


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Hospital Professional

2016

Medisource Hospital Pharmacy Technician of the Year Award 2016

Leonor O’Connor, Pharmacy Technician at St James’s Hospital walked away with the Medisource Hospital Pharmacy Technician of the Year Award. Leonor has been working in the pharmacy in St James's Hospital for the last 14 years. She has been described as someone who constantly motivates her colleagues and is continuously working to improve the role of the pharmacy technician within SJH and also through her volunteer work with the National Association of Hospital Pharmacy Technicians in Ireland. Leonor has been working as a Hospital Pharmacy Technician for over twenty years. She previously worked in the NHS for eight of those years, before returning to work in Ireland. She began her training by completing the Pharmacy Technician Diploma in Trinity College Dublin, the Dispensary Checking Technician course and also a Higher National Certificate in Pharmaceutical Sciences which is a two year course in management and clinical studies for senior technicians. During her time in Scotland within the NHS she was a designated medicines management technician and during that time undertook a project for setting up a ‘Patients Own Drugs’ system, which involved assessing patients own drugs for use within the hospital during their stay. Some initiatives Leonor has led include the establishment of an Acute Medical Assessment Unit Ward based pharmacy technician service; an online pharmacy stores ordering system; development of the Supplies Officer Role and in various quality initiatives. One of her nominees describes her as a professional who is always ‘welcoming, helpful and a hard working person. She is continuously coming up with fresh ideas on how we can change pharmacy procedures to help improve efficiencies within the October 2016 • HPN

Leonor O'Connor, St James's Hospital with Aoife O’Brien, Customer Services Executive, Medisource

Leonor O'Connor, Hospital Pharmacy Technician, St James's Hospital

department. Her enthusiasm and positive attitude is infective and encourages everyone to think in the same positive way.’ St James’s Hospital Pharmacy department is about to undergo a huge change in the coming months. It is relocating, adding an offsite stores area and introducing robotics. Leonor has been happy to take a lead role reviewing all current roles and planning for all the changes and expansion in roles that will come with the new department. While change can make some people nervous, Leonor has encouraged all staff to see it as a positive thing that can only enhance the valuable pharmacy

technician role. And when she is not trying to improve the pharmacy department and the roles of all members of the team, she often runs ten kilometres or participates in various events for charity. Leonor commented, “I have been working in a Pharmacy Technician for over twenty years and I am delighted to receive this Award for my efforts. The role of Pharmacy Technician is changing in many ways as we move towards an era of new technology and the automation of our processes. There are exciting times ahead for us to be greater involved in an expansion of our role assisting in the work of the clinical pharmacists at ward level and I am very proud to be a part of that.

“I would like to thank Medisource for their continued support of our profession, generally and through their continued sponsorship of this Award category highlighted the valuable work technicians bring to the hospital environment.” Paul Boland, Managing Director of Medisource added, “Many congratulations to Leonor on her very deserving win of this Award. She has developed the role extensively for the hospital pharmacy technician and I am delighted for her. We chose this Award because we understand that Technicians are key part of the pharmacy team and the work they do towards helping improve patient care and their role is often not seen.”


Feature 47

Mental Health Management: Schizophrenia Dr Stephen McWilliams presents a vignette of a schizophrenic patient, covering how to diagnose and manage the condition, and the increased potential for a successful recovery. Pause for a moment and think of a pleasant and ordinary young man. Let’s call him Sean. He is 19 years of age and studies engineering at a Dublin university. He has a girlfriend and comes from a supportive family in which there is no history of mental illness. He plays the guitar and attends the occasional rugby match with his brother. He reluctantly admits to smoking a few joints of cannabis at the weekend with friends, but never around exam time. He drinks four pints of lager on Friday and Saturday nights, but rarely gets into trouble. Hearing voices Sean begins to hear the voices of former classmates who bullied him at school. The voices tell him relentlessly he will never amount to anything in life. Sean tries everything from distraction to alcohol to loud music, but nothing will rid him of these voices. They are initially irritating, then frightening. Then Sean begins to notice random people on the street looking at him strangely. The occasional car seems to follow him. Security cameras trouble him. Before long, he realises that the woman reading the news on television is trying to warn him about threats to his life. In response, Sean retreats to his room and rarely ventures outside. He believes this is the only way he can stay safe. He stops attending college and ignores his girlfriend’s phone calls. To be honest, he is a little suspicious of her. His worried parents call the family GP, who refers Sean for a specialist assessment. With some difficulty, his parents persuade

him to keep this appointment.

Dr Stephen McWilliams, Consultant Psychiatrist

A detailed assessment leads to a diagnosis of first-episode psychosis and a concern that he may have evolving schizophrenia. Sean and his parents have many questions. What is schizophrenia? What causes it? How can Sean recover? What is schizophrenia? The lifetime risk of schizophrenia is estimated at around 1 per cent, usually first affecting people between the ages of 15 years and 40 years. It accounts for roughly onein-five psychiatric admissions in Ireland (second only to depressive disorders) and is the most common reason for involuntary admission. It can be profoundly debilitating for the individual and costly for society. According to Behan and co. (2008), the total direct and indirect cost of schizophrenia to the Exchequer in 2006 was more than ¤460 million. The World Health Organisation’s (WHO) International Classification of Diseases (10th Edition, ICD-10) describes schizophrenia as a severe psychotic illness that is not attributable to organic brain disease, is not attributable to alcohol/drug-related intoxication, dependence or withdrawal, and is present prior to any symptoms suggestive of diagnosable mania or depression. The psychotic symptoms must be present on most days for at least a month, and must include at least one of the following: (a) thought echo, insertion, withdrawal or broadcast; (b) auditory hallucinations (usually thirdperson or running commentary); (c) passivity delusions (in which the individual believes their actions, impulses or feelings are controlled by an outside force) or delusional perception; and (d) persistent delusions of other kinds.

In the absence of one of the above, a diagnosis of schizophrenia can still be made on the basis of at least two symptoms from a long list that includes other hallucinations, thought disorder, catatonic behaviours (for example, unconscious physical posturing or mutism) and negative symptoms (for example, apathy, paucity of speech, blunted affect and social withdrawal). Aetiology The aetiology of schizophrenia remains the ‘million dollar’ question to which there is no single answer. We still focus to some degree on the stress-vulnerability model, in that some biological vulnerability factors have been identified, including a complex interaction between genetics and disrupted early development of the nervous system. Obstetric factors, stressors in childhood and adolescence (leading to dopaminergic dysregulation) and social adversity (leading to negative cognitive biases in relation to everyday experiences) all likely increase the risk that a psychotic illness will develop.

Illicit substances add to this risk — especially cannabis, which can increase the lifetime risk of schizophrenia six-fold or more. Interpersonal conflict and high expressed emotion can precipitate a relapse of psychosis. Managing psychosis So, how exactly is psychosis best managed? Noteworthy international guidelines include those by the British Association for Psychopharmacology (BAP), the South London and Maudsley NHS Trust, the Scottish Intercollegiate Guidelines Network (SIGN), the schizophrenia Patient Outcomes Research Team (PORT) and others. The UK National Institute for Health and Care Excellence (NICE) published its updated guidelines in February 2014, with language clearly more recovery-focused to include a greater emphasis on comprehensive multidisciplinary assessment, early intervention, care planning, a collaborative approach to prescribing, physical health monitoring, and phase-specific interventions such as carer information and support, cognitive behaviour

HPN • October 2016


48 Feature Recovery

Schizophrenia

therapy (CBT) and vocational rehabilitation. Specialist referral is almost always needed for someone with a suspected psychosis. Admission to hospital is sometimes appropriate, depending on mental state examination, assessment of safety and the likelihood of an admission being voluntary. Admission allows for the provision of a safe environment for assessment and treatment, and may also aid carers by providing them with a brief period of respite, the opportunity to give collateral information and a resource for carer information and support. Antipsychotic medication is broadly divided into first and second generation (what used to be termed classical and atypical respectively). First-generation antipsychotics (in use since the early 1950s) include haloperidol, chlorpromazine and zuclopenthixol. Effective in the treatment of hallucinations, delusions and thought disorder, they represented the first line in psychosis management during the latter half of the 20th Century, notwithstanding their limited effect on negative symptoms or functional outcome.

October 2016 â&#x20AC;˘ HPN

Clozapine was the first of the second-generation antipsychotics to become available. It remains unparalleled in terms of efficacy, although initial claims about its usefulness in treating negative symptoms may have been overstated. It has a range of idiosyncratic adverse effects, including a potentially fatal agranulocytosis. A vigilant clozapine patientmonitoring service (CPMS) has allowed for the ongoing use of clozapine in treatment-resistant schizophrenia. Other sideeffects include hypersalivation, weight gain, sedation, polyuria, and an increased risk of cardiomyopathy and seizures. Since the early 1990s, newer second-generation antipsychotics have become available, including risperidone, olanzapine, amisulpiride, quetiapine, aripiprazole, ziprasidone and others. The decision about which medication to use will often depend on the side-effect profile. To varying degrees, anti-psychotics lead to sedation, extrapyramidal side-effects (Parkinsonism, akathisia, dystonia and tardive dyskinesia), QTc prolongation, weight gain and raised prolactin, among other less common sideeffects. As second-generation

antipsychotics make up a large proportion of prescriptions in Ireland, cardio-metabolic side-effects are a particular issue for patients. The WHO has highlighted the fact that individuals with schizophrenia have a reduced life expectancy of 10-25 years. Suicide accounts for only a fraction of this. Heavy smoking is two-to-six times more common among people with schizophrenia. Obesity exists in 45-55 per cent, diabetes in 1015 per cent and hypertension in 19-58 per cent. Individuals with schizophrenia receive poorer medical care for their physical problems than do members of the general population. Diagnostic overshadowing frequently occurs and delayed diagnosis often prevents effective care. At the International Early Psychosis Association (IEPA) conference (November 2014) considerable discussion took place on the importance of attention to physical health in schizophrenia management. In this context, the IEPA endorsed the Healthy Active Lives (HeAL) declaration by Dr David Shiers and others. Highlighted was the need to intervene at the start of treatment in terms of physical health monitoring and management of cardiometabolic risk.

So how can Sean (in our vignette above) be guided towards recovery? Wherever possible, the choice of medication is made in partnership with him, taking carersâ&#x20AC;&#x2122; (in this case his parentsâ&#x20AC;&#x2122;) views into account if he agrees. Medications are ideally trialled algorithmically, titrated to a minimum-effective dose, adjusted according to response and tolerability, and assessed over six-to-eight weeks. Longacting injections remain an option, while most guidelines suggest that clozapine is indicated where patients are unresponsive to two different antipsychotics, at least one of which is second-generation. It is important to bear in mind that failure to respond to medication may be explained by inadequate dosage, nonadherence, misdiagnosis or substance misuse. Real recovery, of course, cannot rely on medication alone. Evidence shows that CBT yields both symptomatic and functional improvement, while occupational therapy and vocational rehabilitation initiatives such as Reach and the National Learning Network are also important. Meanwhile, Brown and colleagues have long since theorised on expressed emotion in the domestic setting, describing how high levels of hostility, critical comments and emotional over-involvement can increase the likelihood of relapse. Numerous studies have highlighted the importance of providing accessible information and support for carers and families. Psycho-education is critical. As such, the focus of managing schizophrenia has gradually shifted from simply resolving symptoms. According to Ashok Malla and colleagues (in Canada), a combined approach such as that outlined above applied to first-episode psychosis can result in 70 per cent of individuals returning to work by the end of year one, a figure that rises to 80 per cent by the end of year two. Provided best-practice treatment is collaborative and recovery-focused, individuals like Sean have more hope than ever before.


49 Seven essentials for Sean’s recovery 1. Medication: Sean’s likelihood of overcoming his symptoms will be greatly enhanced by his taking the recommended medication. However, Sean is entitled to be involved fully in any decisions around medication so that, for example, potential sideeffects are discussed and prevented where possible. 2. Substances: Avoiding cannabis and other illicit drugs will improve Sean’s chances of recovery. He might also consider giving up alcohol. 3. Psychology: There is growing evidence that cognitive behavioural therapy (CBT) helps people like Sean to recover and avoid further episodes of psychosis. Progressive muscular

relax-ation and mindfulness meditation may also be useful. There are useful selfhelp books and websites available. 4. Information: Sean and his family will likely benefit from attending psycho-education. Well informed and caring family members are often the best resource individuals with schizophrenia have. Equally, family members should be mindful of their own health and seek help when necessary. 5. Lifestyle: A well structured daily routine will help Sean to remain well. This means having defined activities from 9-5, Monday to Saturday, by engaging in vocational rehabilitation (such as Reach), further education (such as the National Learning Network), voluntary

work or a part time job. These will help Sean rebuild mental stamina, enhance his quality of life and promote recovery. A healthy diet and regular exercise are also important in promoting good mental health and helping to prevent cardio-metabolic problems. 6. Prevention: Sean will benefit from keeping in touch with his psychiatrist, psychologist, community nurse or whoever else he trusts on his specialist team. By attending regular outpatient appointments and knowing how to spot his specific early signs of relapse, he will maximise his chances of recovery. His family can help in this regard. Courses such as the Wellness and Recovery Action Plan (WRAP) are worth considering.

7. Networking: Sean might consider joining a mental health advocacy group or his local service users’ forum. There is often good support to be had from those who have experienced psychosis before. Sean might even help to shape the delivery of a better mental health service for others into the future. References on request.

Dr Stephen McWilliams is a Consultant Psychiatrist and author. He is the clinical lead of the Psychosis Programme at Saint John of God Hospital.

News

New Alzheimer’s treatment on the horizon A long-awaited drug treatment which can halt Alzheimer's disease may be on the horizon after promising results from an early stage clinical trial. Experts are taking care not to build up false hopes about the antibody drug, aducanumab, which clears away sticky protein fragments in the brain linked to Alzheimer's. But according to one leading charity, the first disease-modifying therapy for the devastating brain condition may now be within sight. The last Alzheimer's drug licensed in the UK became available more than a decade ago. Current treatments can reduce symptoms to some extent but doctors have nothing that can halt or slow progression of the disease. Currently there are almost 48,000 people living with dementia in Ireland, but it is estimated that number will rise to 153,157 by 2046 due to population ageing. Alzheimer's is linked to the build-

up of sticky clumps of beta-amyloid peptide - pieces of protein - in the brain. Extensive deposits of the material can be seen in the brains of dead victims. Beta-amyloid toxicity is thought to be a primary cause of the neural dysfunction and degeneration which underlies the disease. Scientists have long known that removing beta-amyloid could lead to a glittering prize - halting or at least slowing Alzheimer's progression. But until now all attempts to target the peptide with a drug have met with failure. Aducanumab is a monoclonal antibody - an immune system agent copied and produced in a laboratory which selectively targets beta-amyloid. Tests on mice genetically engineered to develop a disease similar to Alzheimer's showed that the drug could enter the brain and reduce levels of beta-amyloid in a dose-dependent fashion.

Scientists also conducted an early Phase I trial to evaluate the safety and tolerability of monthly aducanumab injections in patients displaying early symptoms of Alzheimer's disease. A total of 165 patients received monthly infusions of either aducanumab or a placebo "dummy drug" for one year. After 54 weeks of treatment, scans showed that levels of beta-amyloid had been significantly reduced in the brains of patients given the antibody. Higher doses were associated with greater reduction, the researchers reported in the journal Nature. At the higher doses, removal of beta-amyloid was also associated with slower mental decline. However, the preliminary study was not designed to assess aducanumab's clinical effectiveness, which will now have to be tested in larger trials.

Dr Alfred Sandrock, from the Massachusetts-based biotech company Biogen, wrote in the Nature paper: "These results justify further development of aducanumab for the treatment of AD (Alzheimer's disease). Should the slowing of clinical decline be confirmed in ongoing Phase III clinical trials, it would provide compelling support for the amyloid hypothesis. Professor Brian Lawlor, Conolly Norman Professor of Old Age Psychiatry at Trinity College Dublin, said the research was interesting and was positive when it came to the clearance of Betaamyloid and the proof of concept for the drug. But he added that the numbers involved in the clinical trial were small, and we need to await the outcome of the phase 3 trials, which are now underway in the UK and due to finish in 2020.

The US-Swiss team led by

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50 Awards Red Carpet Hospital Professional Awards 2016 – The Red Carpet The fourth annual Hospital Professional Awards were held on Saturday, September 17th in the Hilton DoubleTree Hotel, Dublin. Over 400 of Ireland’s leading hospital professionals were in attendance, including hospital group CEOs, Managers, Consultants, Hospital Pharmacists, Specialists and Clinical Teams to witness who walked off with the coveted 13 titles. Below are some of those who walked the red carpet for this evening of celebrating and recognising excellence.

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13 1: Siobhan and Matt Moran, Director, Bio PharmaChemical Ireland 2: Dr Verena and Rory Murphy, Chair, Cancer Trials Ireland 3: Jennie and Ciaran O’Flaherty, Midland Regional Hospital, Portlaoise 4: Stephen Donnelly, O’Dwyers Pharmacy Cashel, Fiona Ryan, St Luke’s Hospital and Dr Judith Strawbridge, RCSI 5: Dr David and Dr Melanie McNamara, Our Lady’s Children’s Hospital Crumlin

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14 6: Vanessa McAndrew, St Vincent’s Private Hospital and Christina McKim, Mater Private Hospital 7: Dr Ambrose McLoughlin, Chairman, Heartbeat Trust, Dr Jacinta McLoughlin, Mr Jerry O’Wyer, Chief Executive Officer, South South-West Hospitals Group and Carole O’Dwyer 8: Geoff Bradley and Dr Catriona Bradley, Director, Irish Institute of Pharmacy

15 9: Keith Barry and Elaine Murphy, Cork University Hospital 10: Emma Walsh, Ciara Ni Dhubhlaing, St Patrick’s University Hospital and Philip Brady 11: The team from Mater Misericordiae University Hospital 12: Sharon Sutton and Ciara Lang, Our Lady’s Children’s Hospital Crumlin

14: Sheena Cheyne, Kate O’Donnell, Mary McCartan, Eimear McManus, Claire Meaney, Brian Battles, Sadhbh O’Leary and Nessa Walsh, National Rehabilitation Hospital 15: Zoe Duncan, Dolores Keating, Sheenagh McCarthy, Melissa Curley, Audrey Purcell and Amanda Boland, St John of God Hospital

13: Lynne Power, Frances Jordan, Marianne Crowley, Louise Murray, Colin McGill, Ciara Floody, Laura McGillen and Leonor O’Connor, St James’s Hospital

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52 Event Gallery

Beacon Hospital invests over ¤34 million in new diagnostic equipment The Minister for Health Simon Harris TD paid a visit to Beacon Hospital recently to mark the investment of ¤34.2 million by the hospital in state of the art diagnostic equipment and facilities. As well as a ¤14.2 million capital investment in new and expanded facilities in the areas of endoscopy, oncology and urology, the development plan includes a ¤20 million ten-year diagnostic equipment contract with GE Healthcare which will ensure that patients at the hospital will benefit from the most technologically advanced diagnostic imaging and scanning equipment available in Ireland. In his first visit to Beacon Hospital as Minister for Health, Simon Harris TD conducted the official opening of the hospital’s newly expanded endoscopy facility, which has received a ¤7 million investment. Four dedicated endoscopy suites have been fitted out with the latest endoscopic technology and patient management application. The facility will be used by screening and diagnostics, and is available to both public and private patients. More than 6,000 scopes (colonoscopies and endoscopies) were conducted at Beacon Hospital last year, and the expansion will enable it double that figure in the next year. Also included in the capital investment programme is a new 4,000 sq. ft., Cancer Care Day Ward which will see the hospital build its cancer care day unit services by 40%, and an expanded urology department with four dedicated procedure rooms where ambulatory, diagnostic and therapeutic procedures are undertaken. Beacon Hospital’s urology team, one of the largest and most specialised in Ireland, carried out more than 5,000 procedures in 2015.

Pictured was Nurse of Endoscopy Unit Lorraine Cunningham, Chief of Staff at Beacon Hospital Professor Mark Redmond, Minister for Health Simon Harris TD and CEO of Beacon Hospital and cofounder of Beacon Medical Group Michael Cullen. Picture Conor McCabe Photography

NUI Galway Emeritus Professor Awarded Prestigious Research Medal Professor Michael Kane, Emeritus Professor of Physiology at NUI Galway, is the 2016 winner of the Society for Reproduction and Fertility’s premier research award, the Marshall Medal. Professor Kane accepted this prestigious award at the Annual Conference of the Society in Winchester, England recently. Professor Kane was awarded the Marshall Medal in acknowledgement of his major contribution to understanding the factors that influence ovarian follicular growth and pre-implantation embryo development. The Marshall Medal was established in 1963 as an annual award to honour an outstanding researcher in the field of reproductive biology. Previous winners of the award include the Nobel prize winner Bob Edwards for his work developing IVF as a fertility treatment and Hilda Bruce and Wesley Whitten who separately discovered the effect of pheromones on mammalian reproduction. Congratulating Professor Kane, Dr Jim Browne, NUI Galway President said, “This is a wonderful recognition of Professor Michael Kane and his research at NUI Galway over many decades. On behalf of the University, I’d like to join with his colleagues and friends in congratulating Michael on receiving the prestigious Marshall Medal, acknowledging the impact of his research on the field of reproductive physiology.” Most of Professor Kane’s professional academic life was spent at NUI Galway and was Head of the Department of Physiology from 1995 until his retirement in 2006 and he also served as pre-clinical Vice Dean and acting Head of Anatomy during that time. Michael was previously awarded the Conway Medal from the Royal Academy of Medicine in Ireland in 1990, a DSc from the National University of Ireland in 2005 and elected a member of the Royal Irish Academy in 2007.

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St James’s Hospital team get on their Bikes A team from Trinity and St James’s Hospital, Dublin recently took to their bikes to join the UNIPHAR C.R.O.S.S. Atlantic Cycle in support of cancer research at Trinity and St James’s. From 4th through the 8th of September, the 2016 cycle was a 5-day 580-km affair through Dingle, Lahinch, Galway, Clifden & Westport. The cycle is the brainchild of the Friends of C.R.O.S.S. and of Paul Wallace, a rugby legend and a patron of C.R.O.S.S. Paul, along with his brothers Richard and David, and many Irish and international rugby legends, for the fifth year in a row got on their bikes to cycle in aid of C.R.O.S.S., a charity that supports cancer education and research in St James’s Hospital and Trinity. Aware of cancer being a leading cause of death worldwide, the Wallace brothers decided to put energy into helping find solutions for tackling the disease through their support for education and research. Over the last four years the cycle has raised over ¤350,000 which has been invested in the state-of-the-art equipment. To support St James’s Hospital/Trinity cycling team please make a gift via the website https:// www.tcd.ie/development/alumniappeal/ donatecurrency.php. Please put “Cancer cycle” as the specific area of the gift.

David Byrne, Accreditation and Rankings Manager, School of Business; Dr Jessie Elliott, HRB Surgical Research Fellow, Department of Surgery, St. James's Hospital; Professor John Reynolds, Professor of Surgery and Head of Department, Trinity College Dublin, Consultant, St James’s Hospital; Tom Molloy, Director of Public Affairs and Communications; Nick Sparrow, Director, Trinity Development & Alumni

Should it not be High-profile WHO job for Ms Cooke Ms Emer Cooke, a TCD School of Pharmacy and Pharmaceutical Sciences graduate and current member of the School’s Strategic Advisory Board, has recently been appointed as Head of Regulation of Medicines and other Health Technologies with the World Health Organisation (WHO) in Geneva. In this role, Ms Cooke will be responsible for leading WHO's global work on regulation of health technologies (medicines, vaccines, diagnostics and devices), co-ordinating the regulatory teams (Norms and Standards, Prequalification, Regulatory Systems Strengthening, and Safety), and working with member states and international partners to assure the quality, safety and efficacy of appropriate health technologies. Ms Cooke will be vacating the position of Head of International Affairs with the European Medicines Agency (EMA) in November 2016, after a very successful career with the Agency that began in July 2002. Staff in the School of Pharmacy and Pharmaceutical Sciences and colleagues on the Strategic Advisory Board wish Emer every success in her new role.

New Medical Device facility opens at NUI A new ¤68 million centre for medical device research, CÚRAM, has opened at NUI Galway, a move to strengthen the Irish medical technology sector which employs 29,000 people in Ireland. The Science Foundation Ireland research centre will receive an investment of ¤49 million over six years from SFI and industry partners including Boston Scientific, Cook Medical, Medtronic, Mylan and Stryker Instruments and has also secured funding of ¤19 million from the European Union’s Horizon 2020 programme. Its research will advance medical devices to mimic the body’s biology, targeting chronic diseases such as diabetes, Parkinson’s and heart disease. “In the long-term we may have minimally-invasive injections instead of operations for back pain, electrodes which degrade within the body over time, or 3D printed muscles and tendons," Professor Abhay Pandit, Scientific Director of CÚRAM, said. CÚRAM, which has a team of 280 people including more than 250 researchers engaged on current projects, also has six academic partners — University College Dublin, University College Cork, University of Limerick, Trinity College Dublin, The Royal College of Surgeons and NUI Galway, where it is based.

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54 Clinical R&D ARIA STUDY SHOWS SUPERIOR EFFICACY OF TRIUMEQ®▼ FOR TREATMENT-NAÏVE WOMEN LIVING WITH HIV ViiV Healthcare have presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/ lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/ FTC) in 495 treatment-naïve women living with HIV. Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively. ARIA was a noninferiority study with a prespecified analysis for superiority. Both non-inferiority and superiority endpoints were met, with superiority being driven by lower rates of both virological failures and discontinuations due to adverse events (AEs) in the dolutegravir/abacavir/ lamivudine group. “Women account for over half of the almost 35 million adults living with HIV worldwide, yet unfortunately they are consistently under-represented in HIV clinical trials.” said John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare. “For this reason, we are committed to ensuring that the specific treatment needs of women are investigated. This trial not only provides physicians with important additional information about Triumeq, it also builds on the strong body of evidence supporting the efficacy of dolutegravir-based regimens in a broad range of patient populations.” The safety profile of dolutegravir/ abacavir/lamivudine was favourable compared to ATV/r plus TDF/FTC, with fewer drugrelated adverse events (AEs) reported on the dolutegravir/ abacavir/lamivudine arm (33% vs 49%); there were also fewer AEs leading to discontinuation compared to those in the ATV/r plus TDF/FTC arm (4% vs 7%). Drug-related AEs reported in the dolutegravir/abacavir/ lamivudine arm included, nausea (31 individuals / 13%), diarrhoea (12 / 5%), headache (5 / 2%) and dyspepsia (4 / 2%).1 In October 2016 • HPN

the ATV/r plus TDF/FTC group, drug-related AEs included nausea (35 / 14%), diarrhoea (18 / 7%), ocular icterus (18 / 7%), dyspepsia (15 / 6%), headache (14 / 6%) and jaundice (13 / 5%).

BENEPALI®, THE FIRST ETANERCEPT BIOSIMILAR REFERENCING ENBREL®, IS NOW AVAILABLE TO IRISH PATIENTS BENEPALI®, the first etanercept biosimilar referencing Enbrel®, is now available in Ireland for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and plaque psoriasis (PsO). The originator product Enbrel®, available to patients through the HSE’s High Tech Arrangements (HT) programme, cost the Government approximately ¤60 million in 2014 – the second most-prescribed product on the scheme. “Anti-TNFs such as etanercept have revolutionised the outlook for patients living with conditions such as RA,” said Professor Gerry Wilson, Professor of Rheumatology at University College Dublin and Consultant Rheumatologist at St Vincent’s and Mater University Hospitals, Dublin. “The availability of an etanercept biosimilar may increase patient access to these products and allow resources to be directed toward new innovative medicines.” BENEPALI’s® availability comes shortly after the publication of the Health Protection Regulatory Authority’s (HPRA) first biosimilars guide, which is targeted at doctors and provides information on the regulation, prescribing, dispensing and traceability of biosimilar medicines in Ireland. Mr John Church, CEO of Arthritis Ireland, also welcomed the availability of BENEPALI®: “Arthritis Ireland is glad that the significant number of people in Ireland with RA, PsA, AxSpa and PsO may now avail of etanercept at a lower cost. This may potentially expand the number of patients who can benefit from this important treatment option.” “It is great news for patients that, with the introduction of our first biosimilar in Ireland, doctors have a new treatment option that may help reduce

expenditure and support ongoing patient access to antiTNF therapy,” said Mr Darren Clarkson, Regional Director, Biosimilars UK/Ireland at Biogen. “Biogen has a rich heritage in biologics, and we are proud to be launching the first etanercept biosimilar in Ireland.”

NANOBIOTIX ANNOUNCES SUBMISSION FOR FIRST MARKET APPROVAL OF LEAD PRODUCT NBTXR3 IN EUROPE NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, has filed for market approval (CE Marking) in Europe for its lead product, a first-in-class radio-enhancer, NBTXR3. The CE Marking submission package is in particular based on current level of evidence generated in the Act.In.Sarc registration trial for treatment of locally-advanced soft tissue sarcoma (STS) and other NBTXR3 clinical trials. The submission has been made in parallel with the continuation of the Act.In.Sarc study and the wider clinical development of NBTXR3 in different cancer indications. The company filed for CE mark on August 23, and received the confirmation from Gmed (the french notified body), that the evaluation will start this month. The latest guidance given by the notified body for review up to potential CE marking is at least 9 months. Laurent Levy, CEO of Nanobiotix, commented, "This first market approval of NBTXR3 in Europe, is a major step for Nanobiotix, the fruit of more than 10 years of research and development. Recruitment has been a little slower than expected in STS clinical trial but overall we are progressing well in our global plan. With this filing we are closer to helping patients every day in hospitals." The Act.In.Sarc study is a global, randomized Phase II/III multi-center pivotal trial evaluating NBTXR3 in combination with radiotherapy before surgery in comparison to the current standard of care, radiotherapy alone, prior to surgery. 156 patients are expected to be included in the

study. To date, 116 patients have been recruited and 92 patients randomized across 39 sites in 13 countries. Nanobiotix plans to release the conclusion of the interim analysis conducted by an independent committee of experts in the coming months. The independent committee of experts will review (i) the data related to the primary endpoint (Complete Pathological Response Rate), ensure (ii) the safety of all patients enrolled in the study, (iii) the quality of the data collected, and (iv) the continued scientific validity of the study design once two third of the patients (104 patients) have been treated. This analysis will be performed four months after the 104th patient has been randomized (time to complete treatment plus readout).

NOVARTIS PRESENTS NEW POSITIVE DATA Novartis has announced detailed Phase II results showing the fully human monoclonal antibody AMG 334 (erenumab) demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine (CM). Significantly more patients receiving monthly subcutaneous AMG 334 70mg or 140mg experienced a 50% or more reduction in the number of monthly migraine days compared with placebo (40%, 41% and 23%, respectively). The data were presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC) in Scotland. The study included 667 patients who had a mean baseline of approximately 18 migraine days per month, and were randomised to receive either subcutaneous placebo or subcutaneous AMG 334 70mg or 140mg once a month. Across both doses, patients observed a statistically significant 6.6-day reduction from baseline in monthly migraine days compared with 4.2 days observed in those on placebo (p<0.001). A reduction of 50% or more in number of monthly migraine days was observed in 40% and 41% (70mg and 140mg doses, respectively) of individuals in the AMG 334 groups, representing a significantly higher likelihood of response compared to 24% of those receiving placebo (both p<0.001).


55 NOVARTIS BAF312 REDUCES THE RISK OF DISABILITY PROGRESSION IN PIVOTAL PHASE III STUDY IN SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS PATIENTS Novartis have announced positive results of the Phase III EXPAND study showing that oral once-daily BAF312 (siponimod) significantly reduced the risk of disability progression compared with placebo in people with secondary progressive multiple sclerosis (SPMS). SPMS is a form of MS characterised by continuous worsening of neurological function over time, independent of relapses. Topline results of EXPAND were presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), in London, UK. BAF312 is a scientifically designed, selective sphingosine1-phosphate (S1P) receptor modulator. Initial data from the EXPAND study show: · Treatment with BAF312 reduced the risk of three-month confirmed disability progression by 21% compared with placebo (p=0.013). The risk reduction for six-month confirmed disability progression was greater, further supporting robustness of the data. · A consistent reduction in the risk of confirmed disability progression across predefined subgroups, including patients without relapses. · A significant difference in favour of BAF312 compared to placebo in annualized relapse rate, the percent change in brain volume, and change from baseline in the volume of T2 lesions (brain lesions identified by a T2weighted magnetic resonance imaging scan). Difference in change from baseline in the Timed 25-Foot Walk test (T25FW) was not significant. · BAF312 was generally safe and well tolerated, with a profile comparable to other drugs in the same class. “There are very few available treatment options to delay disease progression in SPMS, and there is a high unmet need for effective therapies with an acceptable safety profile for people with the condition,” said Vasant Narasimhan, Global Head

Drug Development and Chief Medical Officer for Novartis. “Novartis is the global leader in understanding the role of S1P receptor modulation in the treatment of MS, and the positive results of the EXPAND study are a continuation of our ongoing efforts to innovate and meet the needs of patients. These data are a positive stride forward in an unserved disease area, and we look forward to evaluating next steps with health authorities.” EXPAND is the largest randomised, controlled study in secondary progressive multiple sclerosis to date. Patients enrolled in EXPAND were representative of a general SPMS population.1 They must have been diagnosed with SPMS and also demonstrated progression of disability in the two years prior to study.1 The majority of patients had non-relapsing SPMS. The mean age at study entry was 48 years, and patients had a median Expanded Disability Status Scale (EDSS) score of 6.0, which corresponds to the use of walking aid.

PATIENT LEVEL RECALL OF GLUCAGEN HYPOKITS The Health Products Regulatory Authority (HPRA) has confirmed that a patient level recall of certain batches of GlucaGen HypoKits used for the emergency treatment of severe low blood glucose is being undertaken. It is advising patients and carers to check the batch number on any GlucaGen Hypokit units they may have at home or in their possession and to return any of the affected product to their pharmacist where a replacement will be provided. GlucaGen HypoKit is packaged with a syringe containing sterile water for injection which is used to prepare the medicine for use. The reason for the recall is that in a small number of units (0.006% approx.) the syringe needle has become detached from the syringe. Units with a detached needle cannot be used to prepare the medicine for administration. GlucaGen HypoKits are used in emergency situations to treat severe hypoglycaemia in children and adults with diabetes mellitus. While a very small number of units are likely to be impacted, a delay in emergency treatment could have significant health consequences and, therefore, units from affected batches should not be used and should be returned to the dispensing

pharmacy where a replacement will be provided. Two batches of Novo Nordisk GlucaGen HypoKit and two batches of PCO Manufacturing GlucaGen Hypokit are being recalled in Ireland and this represents a total of 8,064 units.

TREVICTA®, (PALIPERIDONE PALMITATE A 3-MONTHLY INJECTION), FOR MAINTENANCE TREATMENT OF SCHIZOPHRENIA IS NOW REIMBURSED IN IRELAND Janssen Ireland have announced that TREVICTA® (a 3‑monthly injection paliperidone palmitate) has been reimbursed for the maintenance treatment of schizophrenia in adult patients. TREVICTA is the only treatment for schizophrenia that is administered four times per year providing the longest dosing interval for an antipsychotic medication. It is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION®­, a one-monthly paliperidone palmitate product. TREVICTA received marketing authorisation from the European Medicines Agency in June of this year based on two Phase 3 studies. The first was a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia. The second was a randomised, multi-centre, double‑blind study comparing the efficacy and safety of paliperidone palmitate 3‑monthly and 1-monthly formulations. TREVICTA was found to be at least as effective in preventing relapse as the paliperidone palmitate 1‑monthly formulation and was not associated with any new or unexpected safety signals. The long-term maintenance study showed that 93% of patients remained relapse free with TREVICTA. The treatment also has longer sustained plasma levels than other paliperidone formulations after discontinuation. It allows patients to maintain therapeutic plasma paliperidone levels with fewer administrations compared with existing treatments, which could subsequently improve patients’ functioning and quality of life. The safety and tolerability profile of TREVICTA is consistent with that of other paliperidone formulations. It was not

associated with any new or unexpected adverse events. The majority of adverse events were mild to moderate and did not result in treatment discontinuation in clinical trials. Trevicta exhibited a low rate of potentially prolactinrelated adverse events in clinical trials, experiences by <4% of females and <1% of males. “Janssen scientists discovered one of the first treatments for schizophrenia more than 60 years ago. TREVICTA, now available for Irish patients, is part of our ongoing commitment to improving the lives of people living with schizophrenia,” said Dr Leisha Daly, Country Director, Janssen Ireland. “TREVICTA allows patients to maintain an optimal level of treatment with fewer administrations compared to currently available antipsychotic treatments. This relieves the burden of taking daily medication, reduces the risk of non-adherence and gives patients the opportunity to focus on other elements of their recovery.”

OVER HALF OF ADULTS ARE UNAWARE OF AGE-RELATED MACULAR DEGENERATION Adults across the country have been urged to consider their eye health and avail of free testing for Age-Related Macular Degeneration (AMD), the leading cause of blindness in those over 50 in Ireland. New research reveals that half (50%) of all adults are unaware of AgeRelated Macular Degeneration 2, despite the fact that 7,000 people are diagnosed with it each year, and almost 100,000 people are living with the condition. The aim of the Never Miss The Wonder campaign is to improve knowledge and understanding of Age-Related Macular Degeneration, so it can be diagnosed and treated as early as possible, to help preserve healthy eyesight. Now in its ninth year, AMD Awareness Week is a nationwide health initiative driven by the NCBI - the national sight loss organisation, Fighting Blindness, the Irish College of Ophthalmologists (ICO), the Association of Optometrists Ireland (AOI), and Novartis Ireland. A dedicated mobile testing unit travelled to Cork, Dublin, Galway, Limerick and Waterford during AMD Awareness Week offering free AMD eye tests and information to the public.

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For Pulmonary Arterial Hypertension For Chronic thromboembolic Pulmonary Hypertension For patients like yours Adempas® is the first and only therapy that stimulates soluble guanylate cyclase (sGC) independently of nitric oxide1 Adempas® is the first treatment to demonstrate significant and sustained clinical efficacy alone or in combination with an ERA or non-IV PCA in PAH patients across multiple endpoints2 Adempas® is the first and only pharmacologic treatment to significantly improve exercise capacity and haemodynamic parameters in patients with CTEPH3 Riociguat significantly improved 6MWD and WHO FC in two independent, randomised, double-blind, placebo controlled trials (PATENT-1, CHEST-1).2,3

Adempas®t (Riociguat) This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SPC for how to report adverse reactions.

ABRIDGED PRODUCT INFORMATION

Refer to Summary of Product Characteristics before prescribing. Presentation: Film-coated tablet containing 0.5mg, 1mg, 1.5mg, 2mg and 2.5mg riociguat. Indications: Chronic thromboembolic pulmonary hypertension (CTEPH): treatment of adult patients with WHO functional class II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment to improve exercise capacity. Pulmonary arterial hypertension (PAH): In monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO functional class II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. Dosage and Administration: Adults: Treatment should only be initiated and monitored by a physician experienced in the treatment of CTEPH or PAH. Recommended starting dose: 1mg taken orally, approximately 6-8 hours apart, three times daily for 2 weeks. Increase dose by 0.5mg three times daily every 2 weeks, to maximum of 2.5mg three times daily if systolic blood pressure ≥ 95mmHg. 1.5mg is adequate for some PAH patients. If systolic blood pressure falls below 95mmHg, the dose should be maintained provided the patient does not show any signs or symptoms of hypotension. If at any time during the up-titration phase systolic blood pressure decreases below 95mmHg and the patient shows signs and symptoms of hypotension the current dose should be decreased by 0.5mg three times daily. Individual dose titration at treatment initiation allows adjustment of the dose to the patients needs. The established individual dose should be maintained unless signs and symptoms of hypotension occur. Tablets can generally be taken with or without food. Paediatric: Use of riocguat in children and adolescents should be avoided. Elderly: Exercise particular care during dose titration. Renal Impairment: Severe- Not recommended, Moderate- Exercise particular care during individual dose titration due to risk of hypotension. Hepatic Impairment: Severe-contraindicated, Moderate- Exercise particular care during

individual dose titration due to risk of hypotension. Smokers: Smokers are advised to stop smoking as concentrations of riociguat in smokers are reduced compared to non-smokers. A max dose of 2.5mg three times daily may be required in patients who are smoking or start smoking during treatment. Contraindications: Co-administration with PDE 5 inhibitors (such as sildenafil, tadalfil, vardenafil); severe hepatic impairment (Child Pugh C); hypersensitivity to the active substance or to any of the excipients; pregnancy; co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form including recreational drugs called “poppers”; patients with systolic blood pressure below 95 mm Hg at treatment initiation; patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). Precautions and Warnings: In PAH, studies with Adempas have been mainly performed in forms related to idiopathic or heritable PAH and PAH associated with connective tissue disease. The use of Adempas in other forms of PAH not studied is not recommended. In CEPTH, pulmonary endarterectomy is the treatment of choice as it is potentially curative. Therefore, an expert assessment of operability should be done prior to treatment with Ademapas. Pulmonary veno-occlusive disease (PVOD): Administration of Adempas to PVOD patients is not recommended. Respiratory tract bleeding: Careful monitoring of patients taking anticoagulants is recommended. The risk of serious and fatal respiratory tract bleeding may be further increased under treatment with Adempas, the use should be avoided in patients with a history of serious haemoptysis or who have previously undergone bronchial arterial embolization. Hypotension: Adempas has vasodilatory properties which may result in lowering of the blood pressure. Adempas must not be used in patients with a systolic blood pressure below 95 mmHg. Patients older than 65 years are at increased risk of hypotension. Therefore, caution should be exercised when administering Adempas in these patients. Renal impairment: Data in patients with severe renal impairment (creatinine clearance <30ml/min) are limited and there are no data for patients on dialysis, therefore Adempas is not recommended in these patients. There is increased Adempas exposure in patients with mild and moderate renal impairment. There is a higher risk of hypotension in these patients, particular care should be exercised during individual dose titration. Hepatic impairment: There is no experience in patients with severe hepatic impairment (Child Pugh C); Adempas is contraindicated in these patients. PK data show that higher Adempas exposure was observed in patients with moderate hepatic impairment (Child Pugh B). Particular care should be exercised during individual dose titration.

References: 1. Grimminger F. et al. Eur Respir J 2009; 33: 785-92. 2. Ghofrani H-A et al. New Engl J Med 2013; 369: 330-40 (PATENT-1) and Supplementary Appendix. 3. Ghofrani H-A et al. New Engl J Med 2013; 369: 319-29 (CHEST-1) and Supplementary Appendix. WHO FC = World Health Organization functional class. sGC = soluble guanylate cyclase. 6MWD = 6 minute walking distance

There is no clinical experience with Adempas in patients with elevated liver aminotransferases (>3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin (>2 x ULN) prior to initiation of treatment; Adempas is not recommended in these patients. Smokers: Plasma concentrations of Adempas in smokers are reduced compared to non-smokers. Dose adjustment may be necessary in patients who start or stop smoking during treatment with Adempas. Paediatric Population: The safety and efficacy in children and adolescents below 18 years have not been established. The use in children and in growing adolescents should be avoided. Adempas contains lactose. Interactions: The concomitant use of Adempas with strong multi pathway cytochrome P450 (CYP) and P-glycoprotein (P-gp) / breast cancer resistance protein (BCRP)inhibitors such as azole antimycotics (e.g. ketoconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir) is not recommended, due to the pronounced increase in Adempas exposure. The concomitant use of Adempas with strong CYP1A1 inhibitors, such as the tyrosine kinase inhibitor erlotinib and the immuno-suppressive agent cyclosporine A, may increase Adempas exposure. Blood pressure should be monitored and dose reduction of Adempas be considered. Pregnancy and Lactation: Contraindicated during pregnancy and breast-feeding. Side Effects: Very common: headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhea and vomiting. Common: Gastroenteritis, anaemia, palpitation, hypotension, haemoptysis, epistaxis, nasal congestion, gastritis, gastro-oesophagus reflux disease, dysphagia, gastrointestinal and abdominal pain, constipation, abdominal distension. Uncommon: Pulmonary haemorrhage (fatal pulmonary haemorrhage was reported in uncontrolled long term extension studies. Package Quantities: 42 or 84 film-coated tablets. Legal Category: POM. Marketing Authorisation numbers: EU/1/13/907/001,004,007,010,011,014. Marketing Authorisation Holder: Bayer Pharma AG, 13342 Berlin, Germany. Date of revision: July 2016. © Merck Sharp & Dohme Ireland (Human Health) Limited 2016. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to MSD (Tel: 01-2998700)

Date of preparation: August 2016 CARD-1180850-0001

HPN October 2017  
HPN October 2017  
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